Jazz Pharma Presented Phase 2b Data for JZP-110 for Treatment of EDS Systems in Adults with Narcolepsy

Jazz Pharmaceuticals plc

today presented data from the Phase 2b study evaluating JZP-110 (formerly known as ADX-N05) as a potential new treatment for the symptoms of excessive daytime sleepiness (EDS) in adults with narcolepsy. In the study, all primary and secondary endpoints were met and patients treated with JZP-110 experienced statistically significant improvements in objective and subjective symptoms of EDS. Based on these data, Jazz Pharmaceuticals plans to evaluate JZP-110 in Phase 3 clinical studies in patients with EDS associated with narcolepsy and in patients with EDS associated with obstructive sleep apnea (OSA), pending discussions with regulatory agencies. These data were presented today at a late-breaker session during SLEEP 2014, the 28th Annual Meeting of the Associated Professional Sleep Societies (APSS), in Minneapolis, Minn. The annual SLEEP meeting is the premier U.S. conference for healthcare professionals, advocates and industry partners involved in sleep medicine. "We are committed to developing and commercializing new and differentiated therapies that address unmet patient needs in sleep medicine, and we believe, based on the encouraging results from early clinical trials, that JZP-110 has the potential to significantly help people with narcolepsy and OSA who are experiencing EDS," said Jeffrey Tobias, M.D., executive vice president, research and development, and chief medical officer, Jazz Pharmaceuticals. "As one of the newest additions to our growing sleep clinical development pipeline, we look forward to advancing the Phase 3 clinical program for this product candidate." About the Study This Phase 2b, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the safety and efficacy of JZP-110 over 12 weeks in 93 subjects aged 18-70 years with an ICSD-2[1] diagnosis of narcolepsy. The study was sponsored by Aerial BioPharma, LLC, from which Jazz Pharmaceuticals acquired the rights to JZP-110 in early 2014. Subjects were randomized to once-daily placebo (n=49) or JZP-110 (n=44). JZP-110 was administered at a dose of 150 mg/day during weeks one through four and at a dose of 300 mg/day during weeks five through 12. Co-primary efficacy endpoints measuring JZP-110's effect on EDS were change from baseline to last assessment in the length of time it took to fall asleep as measured by the average sleep onset latency (SOL) on the Maintenance of Wakefulness Test (MWT), an objective measure of the severity of EDS, and symptom improvement as measured by the Clinical Global Impression-Change (CGIC), a subjective physician-completed scale. The change from baseline at weeks four and 12 on the Epworth Sleepiness Scale (ESS), a subjective patient-completed measure of sleepiness, was a secondary endpoint. Patients treated with JZP-110 experienced statistically significant results in both primary endpoints and the secondary endpoint (ESS) at weeks four and 12 compared to those receiving placebo.