Jazz Pharmaceuticals Presents New Data from a Human Abuse Liability (HAL) Study for JZP-110, an Investigational Treatment for Excessive Sleepiness in Patients with Narcolepsy or with Obstructive Sleep Apnea, at 30th Annual SLEEP 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 1200 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," said
"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," said
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 1200 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 1200 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 1200 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
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 on
JZP-110 is a late-stage investigational wake-promoting agent being developed as a treatment of ES in adult patients with narcolepsy or with OSA. JZP-110 acts as a selective Dopamine and Norepinephrine Reuptake Inhibitor (DNRI).
Data from the Phase 2b study of JZP-110 has been accepted and will be published in the journal Sleep. The data show that at doses of 150 mg to 300 mg/day, JZP-110 significantly improved the ability of adults with narcolepsy to stay awake compared to placebo as measured on the Maintenance of Wakefulness Test and significantly reduced subjective symptoms of ES relative to placebo as measured using the Epworth Sleepiness Scale. In this study, JZP-110 had a safety profile that appeared to be consistent with other wake-promoting agents. The most common AEs with JZP-110 vs placebo were insomnia, headache, nausea, diarrhea, decreased appetite, and anxiety. These data were previously presented at a late breaker session during the 28th Annual Meeting of APSS on
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the therapeutic potential of
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-presents-new-data-from-a-human-abuse-liability-hal-study-for-jzp-110-an-investigational-treatment-for-excessive-sleepiness-in-patients-with-narcolepsy-or-with-obstructive-sleep-apnea-at-30th-annual-sleep-m-300284078.html
Investors: Kathee Littrell, Vice President, Investor Relations, Ireland, +353 1 634 7887, U.S., +1 650 496 2717, Media: Laurie Hurley, Vice President, Corporate Affairs, Ireland, +353 1 634 7894, U.S., +1 650 496 2796