BioCentury
ARTICLE | Clinical News

JZP-110: Phase IIb data

July 21, 2014 7:00 AM UTC

A double-blind, U.S. Phase IIb trial in 93 patients with narcolepsy showed that once-daily JZP-110 met the co-primary endpoints of increasing average sleep onset latency as measured by MWT (12.8 vs. 2.1 minutes, p<0.0001) and of improving the proportion of patients whose symptoms were “much improved” or “very much improved” as measured by CGI-C score (86% vs. 38%, p<0.0001) from baseline to week 12 vs. placebo. JZP-110 also met the secondary endpoint of reducing overall sleepiness as measured by ESS score from baseline to week 12 vs. placebo (8.5 vs. 2.5 points, p<0.0001). JZP-110 was generally well tolerated with headache, nausea, diarrhea, insomnia, reduced appetite and anxiety reported as the most common adverse events. Patients received placebo or once-daily 150 mg JZP-110 for 4 weeks followed by once-daily 300 mg JZP-110 for 8 weeks. Data were presented at the SLEEP 2014 meeting in Minneapolis. Jazz said it plans to start Phase III trials with JZP-110 to treat excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, pending discussions with regulatory agencies. ...