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FDA Okays Abuse-Deterrent Opioid for Severe Pain
Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.
In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”
To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.
Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.
“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.
Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.
“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”
A version of this article first appeared on Medscape.com.
Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.
In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”
To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.
Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.
“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.
Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.
“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”
A version of this article first appeared on Medscape.com.
Roxybond, an immediate-release (IR) formulation of oxycodone hydrochloride, is made with Protega’s SentryBond technology, which makes it harder for people to crush, inject, or snort, according to the company.
In a statement from Protega, Paul Howe, the company’s chief commercial officer, said the drug meets an “unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated.”
To determine the tablet’s ability to withstand manipulation, more than 2000 in vitro tests were conducted, according to the release. The findings indicate Roxybond reduces — but does not entirely negate — the potential for intranasal and intravenous abuse.
Roxybond was previously approved in 5-, 15-, and 30-mg doses. The 10 mg option provides clinicians with the ability to better modify side effects, manage titration, and provide precision care for patients on opioid therapy, according to Protega.
“For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions,” the company stated.
Roxybond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or hypersensitivity to oxycodone. The drug is not intended for long-term use unless otherwise determined by a clinician. Roxybond also is subject to the FDA’s Risk Evaluation and Mitigation Strategies for opioids.
“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protega, in a release. “Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse.”
A version of this article first appeared on Medscape.com.
COVID vax: Primary care back at forefront of care delivery
With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.
David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.
Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.
“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.
A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.
“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
The roadblocks to vaccines
More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.
Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.
“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.
It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.
The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.
Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.
“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.
The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.
“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”
Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.
Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.
“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.
The Health Affairs study was supported by the CDC.
A version of this article first appeared on Medscape.com.
With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.
David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.
Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.
“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.
A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.
“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
The roadblocks to vaccines
More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.
Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.
“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.
It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.
The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.
Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.
“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.
The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.
“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”
Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.
Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.
“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.
The Health Affairs study was supported by the CDC.
A version of this article first appeared on Medscape.com.
With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.
David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.
Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.
“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.
A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.
“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
The roadblocks to vaccines
More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.
Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.
“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.
It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.
The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.
Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.
“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.
The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.
“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”
Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.
Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.
“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.
The Health Affairs study was supported by the CDC.
A version of this article first appeared on Medscape.com.