Jazz Pharmaceuticals plc announced results from a Human Abuse Liability (HAL) study of JZP-110, an investigational wake-promoting agent in Phase 3 development for the treatment of excessive sleepiness (ES) in adult patients with narcolepsy or with obstructive sleep apnea (OSA). The data was presented at the SLEEP 2016 meeting.
“The new data from the HAL study demonstrated that each of the doses of JZP-110 that were studied, including the high therapeutic dose of 300 mg and the supratherapeutic doses of 600 mg and 1,200 mg, had consistently lower ratings on the primary endpoint of Peak Liking at the Moment and on the secondary endpoints of Overall Drug Liking and willingness to Take the Drug Again compared to the Schedule IV stimulant phentermine at 90 mg,” says Jack Henningfield, PhD, vice president at Pinney Associates and professor at Johns Hopkins University School of Medicine, in a release. “JZP-110 has a mechanism of action that is distinct from traditional stimulants and these data showed that the abuse potential of JZP-110 differed from that of a traditional stimulant as well.”
Karen Smith, MD, PhD, global head of research and development and chief medical officer at Jazz Pharmaceuticals, says, “Despite current therapies, many patients with narcolepsy and patients with OSA continue to experience excessive sleepiness. The new HAL data help further our understanding of JZP-110’s potential to fill an unmet need for new wake-promoting treatment options.”
About the HAL Study
HAL studies are clinical studies that help assess the relative abuse potential of a medicine. The HAL study was a randomized, double-blind, placebo-controlled, six-sequence crossover study evaluating the abuse potential of JZP-110 relative to the Schedule IV stimulant phentermine in 43 adults with a recent history of recreational polydrug use, including stimulants, who met study entry criteria. Subjects were randomized to one of six test sequences, in which they received a single treatment with one of the six study drugs (JZP-110 at 300 mg, 600 mg, and 1,200 mg; phentermine at 45 mg and 90 mg; and placebo), with a two-day washout period between each treatment.
The study evaluated effects that are predictive of abuse potential. The primary endpoint was Liking at the Moment across the first 12 hours after drug administration based on a subject-reported 100-point bipolar liking/disliking visual analog scale (VAS), a standard measure of abuse potential in HAL studies. Key secondary endpoints were retrospective VAS ratings at 24 hours after drug administration for Overall Next Day Drug Liking and how much the participant would like to Take the Drug Again.
On the primary endpoint, all doses of JZP-110 had significantly lower ratings of peak (Emax) Liking at the Moment compared to 90 mg of phentermine (P<0.05) and had significantly greater ratings of peak Liking at the Moment compared to placebo (P<0.001). On the secondary endpoint of Overall Next Day Drug Liking, JZP-110 at 600 mg and at 1,200 mg had significantly lower measures compared to both doses of phentermine (P<0.05). JZP-110 at 300 mg was not statistically different from 45 mg of phentermine (p=0.070). JZP-110 at 600 mg and at 1,200 mg did not have any statistical difference in Overall Next Day Drug Liking measures compared to placebo. JZP-110 at 300 mg had higher measures of Overall Next Day Drug Liking at 24 hours compared to placebo (p=0.021). On the secondary endpoint of willingness to Take the Drug Again, JZP-110 at all doses had significantly lower measures compared to both doses of phentermine (P<0.05). All doses of JZP-110 had higher ratings of willingness to Take the Drug Again relative to placebo (P<0.05).
Of the 43 adult subjects, 37 completed all six test treatment phases. Two subjects discontinued for treatment emergent adverse events (TEAEs) after receiving 1200 mg of JZP-110. TEAEs were dose-dependent for JZP-110 and phentermine and none were serious or severe. The most frequent TEAEs at the 1200 mg dose of JZP-110 were: hypervigilance, elevated mood, dry mouth, nausea, feelings of relaxation, decreased appetite, hyperhidrosis, insomnia, headache, restlessness, and palpitations.
These data were also presented at the College on Problems of Drug Dependence meeting in Palm Springs, Calif, on June 13, 2016.
New data from a post-hoc analysis from the Phase 2 studies of JZP-110 on its effect on wakefulness was also presented in an oral presentation and poster session at SLEEP 2016.
This sounds awesome after suffering from exhaustion due to narcolepsy. It would be nice to feel human again.
Has anyone heard when it will be available for prescription if it’s approved after the studies are completed?
I’d like to know more about this and if it’s now available for my doctor to prescribe. I have IH and am suffering! I want to live a normal life again.