Jazz Pharmaceuticals plc has enrolled the first patient in a phase 3 clinical trial evaluating the efficacy and safety of JZP-258 for the treatment of idiopathic hypersomnia. JZP-258 is an investigational oxybate mixed-salts oral solution with 90% 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 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,” says Jed Black, MD, senior vice president, sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford Center for Sleep Sciences and Medicine, in a release. “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).
JZP-258 is an oral solution that contains a mixture of oxybate salts, resulting in 90% less sodium content than Xyrem oral solution.