Jazz Pharmaceuticals plc (Nasdaq: JAZZ) 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."