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DENVER—The abuse potential of the investigational drug JZP-110 may be similar to or lower than that of the Schedule IV stimulant phentermine, according to data presented at the 30th Anniversary Meeting of the Associated Professional Sleep Societies. Results also indicate that the 300-mg therapeutic dose of JZP-110 is well tolerated and entails no new safety concerns.
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor and wake-promoting agent under evaluation for the treatment of narcolepsy and obstructive sleep apnea. The use of some therapies for narcolepsy is limited by their abuse potential. Lawrence P. Carter, PhD, Senior Director in Clinical Development at Jazz Pharmaceuticals and Assistant Professor of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences in Little Rock, and colleagues sought to evaluate the abuse potential of JZP-110, compared with phentermine as a positive control in a human abuse liability study.
Eligible participants were healthy individuals between ages 18 and 55, had a self-reported history of recreational polydrug use, and had used a stimulant recreationally 10 or more times in the previous five years and once or more in the previous three months. Participants who tolerated phentermine in a qualification phase and who preferred it to placebo were enrolled in the test phase. In the test phase, participants were randomized to one of six double-blind treatment sequences that included single administration of placebo; 300-mg, 600-mg, and 1,200-mg doses of JZP-110; and 45-mg and 90-mg doses of phentermine. The primary end point was peak rating of Liking at the Moment during the first 12 hours on the Visual Analog Scale (VAS). Secondary end points included retrospective VAS ratings at 24 hours after administration for Overall Drug Liking, and how much the participant would like to take the drug again.
In all, 43 participants (mean age, 29.3) were enrolled, 74.4% of whom were African American. Thirty-seven participants completed the study, and two discontinued the study because of adverse events. Liking at the Moment was generally greater after taking phentermine than after taking JZP-110. For all doses of JZP-110, peak Liking at the Moment was significantly greater than for placebo and significantly less than for 90 mg of phentermine. Retrospective evaluation of Overall Drug Liking for JZP-110 at 600 mg and 1,200 mg was not significantly different from placebo and was significantly less than both doses of phentermine. At all doses of JZP-110, participants were significantly less willing to take the drug again, compared with both doses of phentermine.
—Erik Greb
DENVER—The abuse potential of the investigational drug JZP-110 may be similar to or lower than that of the Schedule IV stimulant phentermine, according to data presented at the 30th Anniversary Meeting of the Associated Professional Sleep Societies. Results also indicate that the 300-mg therapeutic dose of JZP-110 is well tolerated and entails no new safety concerns.
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor and wake-promoting agent under evaluation for the treatment of narcolepsy and obstructive sleep apnea. The use of some therapies for narcolepsy is limited by their abuse potential. Lawrence P. Carter, PhD, Senior Director in Clinical Development at Jazz Pharmaceuticals and Assistant Professor of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences in Little Rock, and colleagues sought to evaluate the abuse potential of JZP-110, compared with phentermine as a positive control in a human abuse liability study.
Eligible participants were healthy individuals between ages 18 and 55, had a self-reported history of recreational polydrug use, and had used a stimulant recreationally 10 or more times in the previous five years and once or more in the previous three months. Participants who tolerated phentermine in a qualification phase and who preferred it to placebo were enrolled in the test phase. In the test phase, participants were randomized to one of six double-blind treatment sequences that included single administration of placebo; 300-mg, 600-mg, and 1,200-mg doses of JZP-110; and 45-mg and 90-mg doses of phentermine. The primary end point was peak rating of Liking at the Moment during the first 12 hours on the Visual Analog Scale (VAS). Secondary end points included retrospective VAS ratings at 24 hours after administration for Overall Drug Liking, and how much the participant would like to take the drug again.
In all, 43 participants (mean age, 29.3) were enrolled, 74.4% of whom were African American. Thirty-seven participants completed the study, and two discontinued the study because of adverse events. Liking at the Moment was generally greater after taking phentermine than after taking JZP-110. For all doses of JZP-110, peak Liking at the Moment was significantly greater than for placebo and significantly less than for 90 mg of phentermine. Retrospective evaluation of Overall Drug Liking for JZP-110 at 600 mg and 1,200 mg was not significantly different from placebo and was significantly less than both doses of phentermine. At all doses of JZP-110, participants were significantly less willing to take the drug again, compared with both doses of phentermine.
—Erik Greb
DENVER—The abuse potential of the investigational drug JZP-110 may be similar to or lower than that of the Schedule IV stimulant phentermine, according to data presented at the 30th Anniversary Meeting of the Associated Professional Sleep Societies. Results also indicate that the 300-mg therapeutic dose of JZP-110 is well tolerated and entails no new safety concerns.
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor and wake-promoting agent under evaluation for the treatment of narcolepsy and obstructive sleep apnea. The use of some therapies for narcolepsy is limited by their abuse potential. Lawrence P. Carter, PhD, Senior Director in Clinical Development at Jazz Pharmaceuticals and Assistant Professor of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences in Little Rock, and colleagues sought to evaluate the abuse potential of JZP-110, compared with phentermine as a positive control in a human abuse liability study.
Eligible participants were healthy individuals between ages 18 and 55, had a self-reported history of recreational polydrug use, and had used a stimulant recreationally 10 or more times in the previous five years and once or more in the previous three months. Participants who tolerated phentermine in a qualification phase and who preferred it to placebo were enrolled in the test phase. In the test phase, participants were randomized to one of six double-blind treatment sequences that included single administration of placebo; 300-mg, 600-mg, and 1,200-mg doses of JZP-110; and 45-mg and 90-mg doses of phentermine. The primary end point was peak rating of Liking at the Moment during the first 12 hours on the Visual Analog Scale (VAS). Secondary end points included retrospective VAS ratings at 24 hours after administration for Overall Drug Liking, and how much the participant would like to take the drug again.
In all, 43 participants (mean age, 29.3) were enrolled, 74.4% of whom were African American. Thirty-seven participants completed the study, and two discontinued the study because of adverse events. Liking at the Moment was generally greater after taking phentermine than after taking JZP-110. For all doses of JZP-110, peak Liking at the Moment was significantly greater than for placebo and significantly less than for 90 mg of phentermine. Retrospective evaluation of Overall Drug Liking for JZP-110 at 600 mg and 1,200 mg was not significantly different from placebo and was significantly less than both doses of phentermine. At all doses of JZP-110, participants were significantly less willing to take the drug again, compared with both doses of phentermine.
—Erik Greb