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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

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Results
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.
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Catalyst Date
Occurred on:
Jun 14, 2016
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Related Keywords Jzp-110, Secondary Endpoint, Primary Endpoint