Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the first patient has been enrolled in a Phase 3 clinical trial evaluating the efficacy and safety of JZP-258 for the treatment of idiopathic hypersomnia, a sleep disorder characterized by chronic and disabling excessive daytime sleepiness (daytime periods of irrepressible need to sleep or daytime lapses into sleep) that is not caused by other conditions known to induce excessive daytime sleepiness. Other symptoms of idiopathic hypersomnia may include prolonged nighttime sleep, long and unrefreshing naps and difficulty waking up from nocturnal sleep or daytime naps. JZP-258 is an investigational oxybate mixed-salts oral solution with 90 percent less sodium than Xyrem® (sodium oxybate) oral solution. JZP-258 is also currently in Phase 3 development for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy.
The JZP-258 clinical trial for patients with idiopathic hypersomnia will be conducted in multiple study centers in the United States (U.S.) and European Union (EU).
"Idiopathic hypersomnia is a debilitating orphan disease and an area of significant unmet patient need since there are no therapies approved to treat it and general awareness of idiopathic hypersomnia is low," said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford Center for Sleep Sciences and Medicine. "This clinical trial is an example of Jazz's commitment to collaborating with the sleep community to advance sleep science and develop potential new treatment options for people with chronic, disabling sleep disorders."
The Phase 3 clinical trial is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study evaluating the efficacy and safety of JZP-258 for the treatment of idiopathic hypersomnia, with an open-label safety extension. Jazz expects to enroll approximately 140 adult patients with idiopathic hypersomnia. The primary endpoint is change in Epworth Sleepiness Scale (ESS) score. Secondary endpoints include the Patient Global Impression of Change (PGIc), the Clinical Global Impression of Change (CGIc), and change in total score on the Hypersomnolence Severity Scale (HSS).
Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03533114).