American Academy of Pain Medicine (AAPM): Annual Meeting

NATIONAL HARBOR, MD. – Fibromyalgia patients who failed to respond to pregabalin showed significant symptom improvement when milnacipran was added to their regimen compared with those who continued taking pregabalin alone, a study involving 332 patients has shown.

The open-label study was the first randomized, controlled trial to show the benefits of adding milnacipran (MLN) to existing pregabalin (PGN) therapy in fibromyalgia patients, according to Dr. Mildred Farmer of Meridien Research in St. Petersburg, Fla., and colleagues. Pregabalin was approved for treating patients with fibromyalgia in 2007; milnacipran was approved for the indication in 2009.

The patients, aged 18-70 years, had baseline Visual Analog Scale (VAS) pain scores of 40 or higher, and they failed to improve on PGN alone during a 4- to 12-week PGN run-in period.

After the run-in period, patients were randomized to 300 or 450 mg/day of PGN (which served as the control group) or a PGN treatment plus 100 mg/day of milnacipran.

After 11 weeks, significantly more patients in the MLN group reported their symptoms were "much improved" or "very much improved" compared with the control group, based on Patients’ Global Impression of Change scale scores. Patients in the MLN group also showed significant improvements in physical and mental function, fatigue, and cognition compared with controls, based on scores on the Multiple Ability Self-Report Questionnaire (–3.69 vs. 1.19).

In addition, "patients receiving MLN added to PGN had significantly greater improvements in VAS 1-week recall pain scores than patients treated with PGN alone," Dr. Farmer said at the annual meeting of the American Academy of Pain Medicine.

The incidence of serious adverse events was not significantly different between the MLN and PGN groups (2.7% vs. 3.4%), nor was the rate of discontinuation significantly different between the two groups (15% vs. 9%). The most common treatment-emergent adverse events in the MLN group were nausea (10%), fatigue (10%), and constipation (10%). Overall, the incidence of adverse events was consistent with, or less than, the adverse events listed in the prescribing information for MLN and PGN, the researchers noted.

No patients in either group had clinically significant increases or decreases in systolic blood pressure.

The results were limited by the open-label nature of the study. However, the data suggest that fibromyalgia patients with an incomplete response to PGN alone might benefit from the addition of MLN. "Milnacipran and pregabalin appear to be complementary in their actions in fibromyalgia patients," Dr. Farmer said.

The study was sponsored by Forest Laboratories and Cypress Bioscience. Two of the study coauthors were employed by these companies. Dr. Farmer is the chief principal investigator and medical director of Meridien Research.

NATIONAL HARBOR, MD. – Fibromyalgia patients who failed to respond to pregabalin showed significant symptom improvement when milnacipran was added to their regimen compared with those who continued taking pregabalin alone, a study involving 332 patients has shown.

The open-label study was the first randomized, controlled trial to show the benefits of adding milnacipran (MLN) to existing pregabalin (PGN) therapy in fibromyalgia patients, according to Dr. Mildred Farmer of Meridien Research in St. Petersburg, Fla., and colleagues. Pregabalin was approved for treating patients with fibromyalgia in 2007; milnacipran was approved for the indication in 2009.

The patients, aged 18-70 years, had baseline Visual Analog Scale (VAS) pain scores of 40 or higher, and they failed to improve on PGN alone during a 4- to 12-week PGN run-in period.

After the run-in period, patients were randomized to 300 or 450 mg/day of PGN (which served as the control group) or a PGN treatment plus 100 mg/day of milnacipran.

After 11 weeks, significantly more patients in the MLN group reported their symptoms were "much improved" or "very much improved" compared with the control group, based on Patients’ Global Impression of Change scale scores. Patients in the MLN group also showed significant improvements in physical and mental function, fatigue, and cognition compared with controls, based on scores on the Multiple Ability Self-Report Questionnaire (–3.69 vs. 1.19).

In addition, "patients receiving MLN added to PGN had significantly greater improvements in VAS 1-week recall pain scores than patients treated with PGN alone," Dr. Farmer said at the annual meeting of the American Academy of Pain Medicine.

The incidence of serious adverse events was not significantly different between the MLN and PGN groups (2.7% vs. 3.4%), nor was the rate of discontinuation significantly different between the two groups (15% vs. 9%). The most common treatment-emergent adverse events in the MLN group were nausea (10%), fatigue (10%), and constipation (10%). Overall, the incidence of adverse events was consistent with, or less than, the adverse events listed in the prescribing information for MLN and PGN, the researchers noted.

No patients in either group had clinically significant increases or decreases in systolic blood pressure.

The results were limited by the open-label nature of the study. However, the data suggest that fibromyalgia patients with an incomplete response to PGN alone might benefit from the addition of MLN. "Milnacipran and pregabalin appear to be complementary in their actions in fibromyalgia patients," Dr. Farmer said.

The study was sponsored by Forest Laboratories and Cypress Bioscience. Two of the study coauthors were employed by these companies. Dr. Farmer is the chief principal investigator and medical director of Meridien Research.

NATIONAL HARBOR, MD. – Fibromyalgia patients who failed to respond to pregabalin showed significant symptom improvement when milnacipran was added to their regimen compared with those who continued taking pregabalin alone, a study involving 332 patients has shown.

The open-label study was the first randomized, controlled trial to show the benefits of adding milnacipran (MLN) to existing pregabalin (PGN) therapy in fibromyalgia patients, according to Dr. Mildred Farmer of Meridien Research in St. Petersburg, Fla., and colleagues. Pregabalin was approved for treating patients with fibromyalgia in 2007; milnacipran was approved for the indication in 2009.

The patients, aged 18-70 years, had baseline Visual Analog Scale (VAS) pain scores of 40 or higher, and they failed to improve on PGN alone during a 4- to 12-week PGN run-in period.

After the run-in period, patients were randomized to 300 or 450 mg/day of PGN (which served as the control group) or a PGN treatment plus 100 mg/day of milnacipran.

After 11 weeks, significantly more patients in the MLN group reported their symptoms were "much improved" or "very much improved" compared with the control group, based on Patients’ Global Impression of Change scale scores. Patients in the MLN group also showed significant improvements in physical and mental function, fatigue, and cognition compared with controls, based on scores on the Multiple Ability Self-Report Questionnaire (–3.69 vs. 1.19).

In addition, "patients receiving MLN added to PGN had significantly greater improvements in VAS 1-week recall pain scores than patients treated with PGN alone," Dr. Farmer said at the annual meeting of the American Academy of Pain Medicine.

The incidence of serious adverse events was not significantly different between the MLN and PGN groups (2.7% vs. 3.4%), nor was the rate of discontinuation significantly different between the two groups (15% vs. 9%). The most common treatment-emergent adverse events in the MLN group were nausea (10%), fatigue (10%), and constipation (10%). Overall, the incidence of adverse events was consistent with, or less than, the adverse events listed in the prescribing information for MLN and PGN, the researchers noted.

No patients in either group had clinically significant increases or decreases in systolic blood pressure.

The results were limited by the open-label nature of the study. However, the data suggest that fibromyalgia patients with an incomplete response to PGN alone might benefit from the addition of MLN. "Milnacipran and pregabalin appear to be complementary in their actions in fibromyalgia patients," Dr. Farmer said.

The study was sponsored by Forest Laboratories and Cypress Bioscience. Two of the study coauthors were employed by these companies. Dr. Farmer is the chief principal investigator and medical director of Meridien Research.

NATIONAL HARBOR, MD. – Fibromyalgia patients who failed to respond to pregabalin showed significant symptom improvement when milnacipran was added to their regimen compared with those who continued taking pregabalin alone, a study involving 332 patients has shown.

The open-label study was the first randomized, controlled trial to show the benefits of adding milnacipran (MLN) to existing pregabalin (PGN) therapy in fibromyalgia patients, according to Dr. Mildred Farmer of Meridien Research in St. Petersburg, Fla., and colleagues. Pregabalin was approved for treating patients with fibromyalgia in 2007; milnacipran was approved for the indication in 2009.

The patients, aged 18-70 years, had baseline Visual Analog Scale (VAS) pain scores of 40 or higher, and they failed to improve on PGN alone during a 4- to 12-week PGN run-in period.

After the run-in period, patients were randomized to 300 or 450 mg/day of PGN (which served as the control group) or a PGN treatment plus 100 mg/day of milnacipran.

After 11 weeks, significantly more patients in the MLN group reported their symptoms were "much improved" or "very much improved" compared with the control group, based on Patients’ Global Impression of Change scale scores. Patients in the MLN group also showed significant improvements in physical and mental function, fatigue, and cognition compared with controls, based on scores on the Multiple Ability Self-Report Questionnaire (–3.69 vs. 1.19).

In addition, "patients receiving MLN added to PGN had significantly greater improvements in VAS 1-week recall pain scores than patients treated with PGN alone," Dr. Farmer said at the annual meeting of the American Academy of Pain Medicine.

The incidence of serious adverse events was not significantly different between the MLN and PGN groups (2.7% vs. 3.4%), nor was the rate of discontinuation significantly different between the two groups (15% vs. 9%). The most common treatment-emergent adverse events in the MLN group were nausea (10%), fatigue (10%), and constipation (10%). Overall, the incidence of adverse events was consistent with, or less than, the adverse events listed in the prescribing information for MLN and PGN, the researchers noted.

No patients in either group had clinically significant increases or decreases in systolic blood pressure.

The results were limited by the open-label nature of the study. However, the data suggest that fibromyalgia patients with an incomplete response to PGN alone might benefit from the addition of MLN. "Milnacipran and pregabalin appear to be complementary in their actions in fibromyalgia patients," Dr. Farmer said.

The study was sponsored by Forest Laboratories and Cypress Bioscience. Two of the study coauthors were employed by these companies. Dr. Farmer is the chief principal investigator and medical director of Meridien Research.

NATIONAL HARBOR, MD. – Fibromyalgia patients who failed to respond to pregabalin showed significant symptom improvement when milnacipran was added to their regimen compared with those who continued taking pregabalin alone, a study involving 332 patients has shown.

The open-label study was the first randomized, controlled trial to show the benefits of adding milnacipran (MLN) to existing pregabalin (PGN) therapy in fibromyalgia patients, according to Dr. Mildred Farmer of Meridien Research in St. Petersburg, Fla., and colleagues. Pregabalin was approved for treating patients with fibromyalgia in 2007; milnacipran was approved for the indication in 2009.

The patients, aged 18-70 years, had baseline Visual Analog Scale (VAS) pain scores of 40 or higher, and they failed to improve on PGN alone during a 4- to 12-week PGN run-in period.

After the run-in period, patients were randomized to 300 or 450 mg/day of PGN (which served as the control group) or a PGN treatment plus 100 mg/day of milnacipran.

After 11 weeks, significantly more patients in the MLN group reported their symptoms were "much improved" or "very much improved" compared with the control group, based on Patients’ Global Impression of Change scale scores. Patients in the MLN group also showed significant improvements in physical and mental function, fatigue, and cognition compared with controls, based on scores on the Multiple Ability Self-Report Questionnaire (–3.69 vs. 1.19).

In addition, "patients receiving MLN added to PGN had significantly greater improvements in VAS 1-week recall pain scores than patients treated with PGN alone," Dr. Farmer said at the annual meeting of the American Academy of Pain Medicine.

The incidence of serious adverse events was not significantly different between the MLN and PGN groups (2.7% vs. 3.4%), nor was the rate of discontinuation significantly different between the two groups (15% vs. 9%). The most common treatment-emergent adverse events in the MLN group were nausea (10%), fatigue (10%), and constipation (10%). Overall, the incidence of adverse events was consistent with, or less than, the adverse events listed in the prescribing information for MLN and PGN, the researchers noted.

No patients in either group had clinically significant increases or decreases in systolic blood pressure.

The results were limited by the open-label nature of the study. However, the data suggest that fibromyalgia patients with an incomplete response to PGN alone might benefit from the addition of MLN. "Milnacipran and pregabalin appear to be complementary in their actions in fibromyalgia patients," Dr. Farmer said.

The study was sponsored by Forest Laboratories and Cypress Bioscience. Two of the study coauthors were employed by these companies. Dr. Farmer is the chief principal investigator and medical director of Meridien Research.

NATIONAL HARBOR, MD. – Fibromyalgia patients who failed to respond to pregabalin showed significant symptom improvement when milnacipran was added to their regimen compared with those who continued taking pregabalin alone, a study involving 332 patients has shown.

The open-label study was the first randomized, controlled trial to show the benefits of adding milnacipran (MLN) to existing pregabalin (PGN) therapy in fibromyalgia patients, according to Dr. Mildred Farmer of Meridien Research in St. Petersburg, Fla., and colleagues. Pregabalin was approved for treating patients with fibromyalgia in 2007; milnacipran was approved for the indication in 2009.

The patients, aged 18-70 years, had baseline Visual Analog Scale (VAS) pain scores of 40 or higher, and they failed to improve on PGN alone during a 4- to 12-week PGN run-in period.

After the run-in period, patients were randomized to 300 or 450 mg/day of PGN (which served as the control group) or a PGN treatment plus 100 mg/day of milnacipran.

After 11 weeks, significantly more patients in the MLN group reported their symptoms were "much improved" or "very much improved" compared with the control group, based on Patients’ Global Impression of Change scale scores. Patients in the MLN group also showed significant improvements in physical and mental function, fatigue, and cognition compared with controls, based on scores on the Multiple Ability Self-Report Questionnaire (–3.69 vs. 1.19).

In addition, "patients receiving MLN added to PGN had significantly greater improvements in VAS 1-week recall pain scores than patients treated with PGN alone," Dr. Farmer said at the annual meeting of the American Academy of Pain Medicine.

The incidence of serious adverse events was not significantly different between the MLN and PGN groups (2.7% vs. 3.4%), nor was the rate of discontinuation significantly different between the two groups (15% vs. 9%). The most common treatment-emergent adverse events in the MLN group were nausea (10%), fatigue (10%), and constipation (10%). Overall, the incidence of adverse events was consistent with, or less than, the adverse events listed in the prescribing information for MLN and PGN, the researchers noted.

No patients in either group had clinically significant increases or decreases in systolic blood pressure.

The results were limited by the open-label nature of the study. However, the data suggest that fibromyalgia patients with an incomplete response to PGN alone might benefit from the addition of MLN. "Milnacipran and pregabalin appear to be complementary in their actions in fibromyalgia patients," Dr. Farmer said.

The study was sponsored by Forest Laboratories and Cypress Bioscience. Two of the study coauthors were employed by these companies. Dr. Farmer is the chief principal investigator and medical director of Meridien Research.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Opioid misuse, and substance abuse in general, is a growing problem among cancer patients and survivors, according to a panel of experts at the annual meeting of the American Academy of Pain Medicine.

With the number of cancer survivors – people who can live for years and decades after diagnosis – on the rise, clinicians are seeing a corresponding growth in risk for pain medication addiction, they said. In addition, earlier cancer diagnoses can mean more patients may commence cancer therapy with a history of substance abuse.

"We’re starting to see a lot more in the way of substance abuse of every stripe. ... There are a lot of folks making it to tertiary cancer care centers with a history of addiction," said Steven D. Passik, Ph.D., a professor of clinical psychiatry at Vanderbilt University in Nashville, Tenn.

He gave the example of a female patient who had a preexisting polysubstance abuse problem and lived with metastatic breast cancer for 11 years. "When I first started in this field, this woman’s life expectancy would have been measured in months, and now it’s measured in years to decades," he said, introducing the challenges of tailoring long-term pain management programs for patients who are at risk of substance abuse.

Oncologists had not dealt much with substance abuse, because cancer is primarily a disease of older people, and addiction problems tend to manifest by age 35, Dr. Passik said. Oncologists and pain management physicians "will now have to worry about a small but very labor-intensive subpopulation of the cancer population. But you have to identify them," he continued, adding that "screening for substance abuse in the cancer setting ... has still not taken root."

Screening Tool Introduced

Dr. Dhanalakshmi Koyyalagunta, a pain management specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said that clinicians there started using the short form of the SOAPP (Screener and Opioid Assessment for Patients With Pain) tool a little more than 2 years ago. This is a five-question assessment. Dr. Koyyalagunta said that clinicians at M.D. Anderson use a score of 4 or more as an indication that an individual is at high risk for substance abuse.

A review of 524 charts with completed SOAPP data found that more than a quarter of cancer patients (29%) were at high risk, she said, noting that the high-risk group included 43% of patients aged 18-35 years, 27% of patients older than 35 years, 72% of smokers, 40% of those who were unemployed, 60% of those with a history of drug use, and 32% of those with a history of alcohol abuse.

Although the true prevalence of substance abuse in the overall population of long-term cancer survivors is unknown, clinicians do know that there is a high incidence of comorbid anxiety and depression, added Dr. Koyyalagunta. It is very important to address any depression, anxiety, or other comorbid psychiatric conditions along with the pain, she said: "There’s a lot of chemical coping associated with these comorbidities."

The best treatment approach is to put together a multidisciplinary team that can develop an integrated treatment plan, said Diane M. Novy, Ph.D., a professor of pain medicine at M.D. Anderson. For example, a psychologist or social worker can address coexisting conditions such as affective disorders; acute stress related to cancer and cancer treatment; family problems; and work-related issues.

No Self-Titration for Pain Management

Pain management in cancer patients, particularly in older patients, tends to rely on self-titration: Take as much as you need, observed Dr. Passik. "It doesn’t hurt low-risk people to have a self-titration model, but you can’t apply that to high-risk people. That’s the recipe for a public health disaster," he warned.

Add in the need for long-term treatment, and problems associated with opioid exposure "now have ample time to play themselves out in terrible fashion," he said. Any opioid treatment strategy that he might use in high-risk patients with an expected 3-6 months of life would be inappropriate for a high-risk patient who was likely to survive for many years, he observed.

"All of us do have trouble with how we handle these patients long term," agreed Dr. Koyyalagunta. "We see a fair number of patients, and it may not be as easy as in the chronic pain setting, where you may have an exit strategy or have an alternative plan – especially in patients with active cancer."

Nonetheless, strategies and tools from the noncancer chronic pain world can be used in the cancer setting, said Dr. Koyyalagunta. These include assessment and differential diagnosis, screening, informed consent, ongoing psychiatric care, frequent outpatient visits, and documentation. "It’s pretty much the same set of principles, but adapting it to a cancer setting," she said.

Dr. Novy concurred. "For people who are at risk, we see them more frequently. We involve their families in the treatment. We encourage the use of a pill box and pill count. We also monitor with random urine screens," she said, adding that M.D. Anderson is also starting to use an opioid compliance checklist similar to the COMM (Current Opioid Misuse Measure) that was developed by Robert N. Jamison, Ph.D., at Brigham and Women’s Hospital in Boston (Pain 2007;130:144-56).

Dr. Passik reported that he has received honoraria from Cephalon Inc., King Pharmaceuticals Inc. (now part of Pfizer Inc.), Pricara (a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.), and Purdue Pharma LP. Dr. Koyyalagunta and Dr. Novy both reported that they have no relevant financial relationships.

NATIONAL HARBOR, MD. – Topical diclofenac sodium 1% gel was as well tolerated as placebo, based on data from 1,426 patients with knee osteoarthritis and 783 patients with hand osteoarthritis.

Findings from previous studies have shown that diclofenac sodium 1% gel (DSG) is effective in treating knee and hand osteoarthritis (OA), but safety data were limited, said Dr. John H. Peniston of Feasterville (Pa.) Family Health Clinic.

In this pooled analysis, the researchers reviewed data from patients aged 35 years and older with knee OA and aged 40 years and older with hand OA. The findings were presented in a poster at the annual meeting of the American Academy of Pain Medicine.

In the group with knee OA, 721 patients were randomized to DSG and 705 to a placebo gel. The most common adverse events were application site related; these occurred in 406 (56.3%) of the DSG patients and 340 (48.2%) of the placebo patients. The incidence of gastrointestinal, cardiovascular, hepatic, or renal adverse events (AEs) was similar between the two groups. The only serious AE potentially related to treatment was a deep-vein thrombosis and pulmonary embolism that developed in an 80-year-old woman with multiple cardiovascular–risk factors, the researchers noted. The most common treatment-emergent AE was headache, reported in approximately 15% of patients in each group.

In the group with hand OA, 400 patients were randomized to DSG and 383 to a placebo gel. Application site events were the most common AEs, occurring in 163 (40.8%) of the DSG patients and 139 (36.3%) of the placebo patients. Rates of cardiovascular, gastrointestinal, renal, and hepatic AEs were similar between the groups. Treatment-related gastrointestinal events occurred in two patients in the DSG group and one in the placebo group. None of the cardiovascular or serious AEs in either group were considered treatment-related, the researchers wrote. However, two patients with hand OA in both the active treatment and placebo groups experienced liver-enzyme elevation to three times the upper limit of normal. The most common treatment-emergent AE was headache, reported by 9% of patients in the DSG group and 10% of the placebo group.

"In general, adverse events with diclofenac sodium were mild and resolved without the need for additional treatment, consistent with a favorable tolerability profile," the researchers said.

The clinical trials for DSG were funded by Novartis, and this post hoc analysis was funded by Endo Pharmaceuticals. Dr. Peniston said he had no financial conflicts to disclose, but several study coauthors were employed by either Novartis or Endo.

NATIONAL HARBOR, MD. – Topical diclofenac sodium 1% gel was as well tolerated as placebo, based on data from 1,426 patients with knee osteoarthritis and 783 patients with hand osteoarthritis.

Findings from previous studies have shown that diclofenac sodium 1% gel (DSG) is effective in treating knee and hand osteoarthritis (OA), but safety data were limited, said Dr. John H. Peniston of Feasterville (Pa.) Family Health Clinic.

In this pooled analysis, the researchers reviewed data from patients aged 35 years and older with knee OA and aged 40 years and older with hand OA. The findings were presented in a poster at the annual meeting of the American Academy of Pain Medicine.

In the group with knee OA, 721 patients were randomized to DSG and 705 to a placebo gel. The most common adverse events were application site related; these occurred in 406 (56.3%) of the DSG patients and 340 (48.2%) of the placebo patients. The incidence of gastrointestinal, cardiovascular, hepatic, or renal adverse events (AEs) was similar between the two groups. The only serious AE potentially related to treatment was a deep-vein thrombosis and pulmonary embolism that developed in an 80-year-old woman with multiple cardiovascular–risk factors, the researchers noted. The most common treatment-emergent AE was headache, reported in approximately 15% of patients in each group.

In the group with hand OA, 400 patients were randomized to DSG and 383 to a placebo gel. Application site events were the most common AEs, occurring in 163 (40.8%) of the DSG patients and 139 (36.3%) of the placebo patients. Rates of cardiovascular, gastrointestinal, renal, and hepatic AEs were similar between the groups. Treatment-related gastrointestinal events occurred in two patients in the DSG group and one in the placebo group. None of the cardiovascular or serious AEs in either group were considered treatment-related, the researchers wrote. However, two patients with hand OA in both the active treatment and placebo groups experienced liver-enzyme elevation to three times the upper limit of normal. The most common treatment-emergent AE was headache, reported by 9% of patients in the DSG group and 10% of the placebo group.

"In general, adverse events with diclofenac sodium were mild and resolved without the need for additional treatment, consistent with a favorable tolerability profile," the researchers said.

The clinical trials for DSG were funded by Novartis, and this post hoc analysis was funded by Endo Pharmaceuticals. Dr. Peniston said he had no financial conflicts to disclose, but several study coauthors were employed by either Novartis or Endo.

NATIONAL HARBOR, MD. – Topical diclofenac sodium 1% gel was as well tolerated as placebo, based on data from 1,426 patients with knee osteoarthritis and 783 patients with hand osteoarthritis.

Findings from previous studies have shown that diclofenac sodium 1% gel (DSG) is effective in treating knee and hand osteoarthritis (OA), but safety data were limited, said Dr. John H. Peniston of Feasterville (Pa.) Family Health Clinic.

In this pooled analysis, the researchers reviewed data from patients aged 35 years and older with knee OA and aged 40 years and older with hand OA. The findings were presented in a poster at the annual meeting of the American Academy of Pain Medicine.

In the group with knee OA, 721 patients were randomized to DSG and 705 to a placebo gel. The most common adverse events were application site related; these occurred in 406 (56.3%) of the DSG patients and 340 (48.2%) of the placebo patients. The incidence of gastrointestinal, cardiovascular, hepatic, or renal adverse events (AEs) was similar between the two groups. The only serious AE potentially related to treatment was a deep-vein thrombosis and pulmonary embolism that developed in an 80-year-old woman with multiple cardiovascular–risk factors, the researchers noted. The most common treatment-emergent AE was headache, reported in approximately 15% of patients in each group.

In the group with hand OA, 400 patients were randomized to DSG and 383 to a placebo gel. Application site events were the most common AEs, occurring in 163 (40.8%) of the DSG patients and 139 (36.3%) of the placebo patients. Rates of cardiovascular, gastrointestinal, renal, and hepatic AEs were similar between the groups. Treatment-related gastrointestinal events occurred in two patients in the DSG group and one in the placebo group. None of the cardiovascular or serious AEs in either group were considered treatment-related, the researchers wrote. However, two patients with hand OA in both the active treatment and placebo groups experienced liver-enzyme elevation to three times the upper limit of normal. The most common treatment-emergent AE was headache, reported by 9% of patients in the DSG group and 10% of the placebo group.

"In general, adverse events with diclofenac sodium were mild and resolved without the need for additional treatment, consistent with a favorable tolerability profile," the researchers said.

The clinical trials for DSG were funded by Novartis, and this post hoc analysis was funded by Endo Pharmaceuticals. Dr. Peniston said he had no financial conflicts to disclose, but several study coauthors were employed by either Novartis or Endo.

NATIONAL HARBOR, MD. – Topical diclofenac sodium 1% gel was as well tolerated as placebo, based on data from 1,426 patients with knee osteoarthritis and 783 patients with hand osteoarthritis.

Findings from previous studies have shown that diclofenac sodium 1% gel (DSG) is effective in treating knee and hand osteoarthritis (OA), but safety data were limited, said Dr. John H. Peniston of Feasterville (Pa.) Family Health Clinic.

In this pooled analysis, the researchers reviewed data from patients aged 35 years and older with knee OA and aged 40 years and older with hand OA. The findings were presented in a poster at the annual meeting of the American Academy of Pain Medicine.

In the group with knee OA, 721 patients were randomized to DSG and 705 to a placebo gel. The most common adverse events were application site related; these occurred in 406 (56.3%) of the DSG patients and 340 (48.2%) of the placebo patients. The incidence of gastrointestinal, cardiovascular, hepatic, or renal adverse events (AEs) was similar between the two groups. The only serious AE potentially related to treatment was a deep-vein thrombosis and pulmonary embolism that developed in an 80-year-old woman with multiple cardiovascular–risk factors, the researchers noted. The most common treatment-emergent AE was headache, reported in approximately 15% of patients in each group.

In the group with hand OA, 400 patients were randomized to DSG and 383 to a placebo gel. Application site events were the most common AEs, occurring in 163 (40.8%) of the DSG patients and 139 (36.3%) of the placebo patients. Rates of cardiovascular, gastrointestinal, renal, and hepatic AEs were similar between the groups. Treatment-related gastrointestinal events occurred in two patients in the DSG group and one in the placebo group. None of the cardiovascular or serious AEs in either group were considered treatment-related, the researchers wrote. However, two patients with hand OA in both the active treatment and placebo groups experienced liver-enzyme elevation to three times the upper limit of normal. The most common treatment-emergent AE was headache, reported by 9% of patients in the DSG group and 10% of the placebo group.

"In general, adverse events with diclofenac sodium were mild and resolved without the need for additional treatment, consistent with a favorable tolerability profile," the researchers said.

The clinical trials for DSG were funded by Novartis, and this post hoc analysis was funded by Endo Pharmaceuticals. Dr. Peniston said he had no financial conflicts to disclose, but several study coauthors were employed by either Novartis or Endo.

NATIONAL HARBOR, MD. – Topical diclofenac sodium 1% gel was as well tolerated as placebo, based on data from 1,426 patients with knee osteoarthritis and 783 patients with hand osteoarthritis.

Findings from previous studies have shown that diclofenac sodium 1% gel (DSG) is effective in treating knee and hand osteoarthritis (OA), but safety data were limited, said Dr. John H. Peniston of Feasterville (Pa.) Family Health Clinic.

In this pooled analysis, the researchers reviewed data from patients aged 35 years and older with knee OA and aged 40 years and older with hand OA. The findings were presented in a poster at the annual meeting of the American Academy of Pain Medicine.

In the group with knee OA, 721 patients were randomized to DSG and 705 to a placebo gel. The most common adverse events were application site related; these occurred in 406 (56.3%) of the DSG patients and 340 (48.2%) of the placebo patients. The incidence of gastrointestinal, cardiovascular, hepatic, or renal adverse events (AEs) was similar between the two groups. The only serious AE potentially related to treatment was a deep-vein thrombosis and pulmonary embolism that developed in an 80-year-old woman with multiple cardiovascular–risk factors, the researchers noted. The most common treatment-emergent AE was headache, reported in approximately 15% of patients in each group.

In the group with hand OA, 400 patients were randomized to DSG and 383 to a placebo gel. Application site events were the most common AEs, occurring in 163 (40.8%) of the DSG patients and 139 (36.3%) of the placebo patients. Rates of cardiovascular, gastrointestinal, renal, and hepatic AEs were similar between the groups. Treatment-related gastrointestinal events occurred in two patients in the DSG group and one in the placebo group. None of the cardiovascular or serious AEs in either group were considered treatment-related, the researchers wrote. However, two patients with hand OA in both the active treatment and placebo groups experienced liver-enzyme elevation to three times the upper limit of normal. The most common treatment-emergent AE was headache, reported by 9% of patients in the DSG group and 10% of the placebo group.

"In general, adverse events with diclofenac sodium were mild and resolved without the need for additional treatment, consistent with a favorable tolerability profile," the researchers said.

The clinical trials for DSG were funded by Novartis, and this post hoc analysis was funded by Endo Pharmaceuticals. Dr. Peniston said he had no financial conflicts to disclose, but several study coauthors were employed by either Novartis or Endo.

NATIONAL HARBOR, MD. – Topical diclofenac sodium 1% gel was as well tolerated as placebo, based on data from 1,426 patients with knee osteoarthritis and 783 patients with hand osteoarthritis.

Findings from previous studies have shown that diclofenac sodium 1% gel (DSG) is effective in treating knee and hand osteoarthritis (OA), but safety data were limited, said Dr. John H. Peniston of Feasterville (Pa.) Family Health Clinic.

In this pooled analysis, the researchers reviewed data from patients aged 35 years and older with knee OA and aged 40 years and older with hand OA. The findings were presented in a poster at the annual meeting of the American Academy of Pain Medicine.

In the group with knee OA, 721 patients were randomized to DSG and 705 to a placebo gel. The most common adverse events were application site related; these occurred in 406 (56.3%) of the DSG patients and 340 (48.2%) of the placebo patients. The incidence of gastrointestinal, cardiovascular, hepatic, or renal adverse events (AEs) was similar between the two groups. The only serious AE potentially related to treatment was a deep-vein thrombosis and pulmonary embolism that developed in an 80-year-old woman with multiple cardiovascular–risk factors, the researchers noted. The most common treatment-emergent AE was headache, reported in approximately 15% of patients in each group.

In the group with hand OA, 400 patients were randomized to DSG and 383 to a placebo gel. Application site events were the most common AEs, occurring in 163 (40.8%) of the DSG patients and 139 (36.3%) of the placebo patients. Rates of cardiovascular, gastrointestinal, renal, and hepatic AEs were similar between the groups. Treatment-related gastrointestinal events occurred in two patients in the DSG group and one in the placebo group. None of the cardiovascular or serious AEs in either group were considered treatment-related, the researchers wrote. However, two patients with hand OA in both the active treatment and placebo groups experienced liver-enzyme elevation to three times the upper limit of normal. The most common treatment-emergent AE was headache, reported by 9% of patients in the DSG group and 10% of the placebo group.

"In general, adverse events with diclofenac sodium were mild and resolved without the need for additional treatment, consistent with a favorable tolerability profile," the researchers said.

The clinical trials for DSG were funded by Novartis, and this post hoc analysis was funded by Endo Pharmaceuticals. Dr. Peniston said he had no financial conflicts to disclose, but several study coauthors were employed by either Novartis or Endo.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.

NATIONAL HARBOR, MD. – Pharmaceutical companies are stepping up to address increasing opioid abuse and misuse by developing innovative abuse-deterrent formulations and drug delivery systems, Dr. Lynn R. Webster said at the annual meeting of the American Academy of Pain Medicine.

Dr. Webster discussed several new opioid formulations that are currently available and some promising technologies in the pipeline. Dr. Webster is board certified in anesthesiology and pain medicine and is certified in addiction medicine. He is also the medical director and founder of the Lifetree Clinical Research and Pain Clinic in Salt Lake City.

New Opioids. In January 2011, the Food and Drug Administration approved Abstral (Prostrakan), a fentanyl transmucosal tablet indicated for the management of breakthrough cancer pain in adults. As an alternative to oral tablets or injections of fentanyl pain medications, the quick-dissolving tablet is placed under the tongue, providing very fast relief for cancer-related pain in patients already receiving opioids for pain treatment.

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone indicated for once-daily administration for the management of moderate to severe pain in opioid-tolerant patients who require continuous, around-the-clock opioid analgesia for an extended period. Exalgo (Mallinckrodt) is not intended for use as an as-needed analgesic. The formulation utilizes a new osmotic, controlled-release oral delivery system in which osmosis attracts water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for effective levels of hydromorphone to be released and 4-5 days for drug levels to reach a steady state in the body, Dr. Webster said.

There has been a resurgence of interest in buprenorphine. This drug has been around for several decades, but is now being used to treat chronic pain. Buprenorphine is a partial mu-opioid agonist, an antagonist at the kappa-opioid receptor, and a partial agonist at the ORL1/nociceptin and delta-opioid receptors. "There is a little bit of complexity with how the pharmacology of this drug works. We probably don’t understand clinically what all of that means yet," Dr. Webster said. Buprenorphine is the only opioid classified as a schedule III drug, making it an attractive choice for pain management. Buprenorphine also is associated with fewer of the side effects typical of opioids, such as respiratory depression.

In 2010, the FDA approved Butrans, an extended-release buprenorphine patch (Purdue Pharma), in 5-, 10- and 20-mcg/hour doses. The drug is indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period.

Notably, Subutex (buprenorphine monotherapy) and Suboxone (a buprenorphine/naloxone combination product) are approved for use in opioid addiction treatment, though other forms of the drug are not. However, other forms of buprenorphine are commonly used off-label for the management of addiction disorders, Dr. Webster said. Because buprenorphine is an opioid partial agonist, its maximal effects are less than those of full agonists (like heroin and methadone). At low doses, buprenorphine is thought to produce enough of an agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine has poor oral bioavailability and only moderate sublingual bioavailability.

In the Pipeline. Acurox (Acura Pharmaceuticals and King Pharmaceuticals [now part of Pfizer]) is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox is formulated so that if the tablets are dissolved in an attempt to extract the opioid for intravenous injection, the tablets turn into a viscous gel mixture with the active drug trapped in the gel. The Aversion technology used also causes burning and irritation of the nasal passages if the drug is crushed and snorted.

Last year, the FDA rejected an application for a version of the drug containing niacin, which was formulated so that the uncomfortable "niacin flush" would deter overuse of the drug. In February 2011, the FDA accepted a new drug application for Acurox (oxycodone) tablets without niacin.

MoxDuo (QRxPharma) is an immediate-release dual opioid intended for the acute management of moderate to severe pain. The drug is a combination of morphine and oxycodone that has been clinically shown to have a synergistic effect on pain with a significant reduction of total opioid dose and side effects.

"This formulation is built upon that thought that there are different receptor selectivities to an opioid," Dr. Webster said. Because opioid receptors differ, "you can get enhanced analgesia with using overall less morphine equivalents, or you could get fewer side effects with the same level of analgesia, when you combine two different opioids."

Collegium Pharmaceuticals is developing an abuse-deterrent, sustained-release oral oxycodone formulation (COL-003). The DETERx delivery technology consists of a multiparticulate matrix formulation in a capsule that is designed to be less susceptible to common methods of tampering, such as crushing or chewing prior to ingestion. Company studies showed that the plasma profile for the new-formulation pill was bioequivalent whether it was chewed or taken whole as intended. "It’s an abuse-resistant formulation in that they can’t extract more than is intended for its delivery," Dr. Webster said.

Remoxy (Pain Therapeutics and King Pharmaceuticals) is a long-acting oral oxycodone for the treatment of moderate to severe chronic pain. "This is what I consider an opioid-resistant formulation, meaning it’s got a barrier that is hard to crush, hard to manipulate; and it’s hard to extract" the oxycodone, Dr. Webster said. "It can’t be chewed, snorted, or injected very easily."

A new transmucosal buprenorphine patch is also in the trial phase. According to PharmacoFore, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology deters prescription drug abuse at a molecular level.

"This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are ‘activated’ to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested)," the company noted on its Web site.

Essentially, an opioid molecule – any opioid – is attached to the delivery compound. "It’s kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will ... allow that drug to be released," Dr. Webster said. The clock determines how much time it will take for the active compound to be released.

"It’s very early on," he cautioned. The delivery system is in phase I trials. Still, "it looks very interesting that they have the technology now to address multipill abuse. There are ways to design the same technologies so that the triggering system will only allow a certain number of pills or milligrams of medication to be absorbed." Thus, regardless of how many pills an individual takes, no more than the prescribed dose is bioavailable.

Dr. Webster reported that he has significant financial relationships with a number of pharmaceutical companies, including King Pharmaceuticals and Collegium Pharmaceutical.