Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating JZP-258 for the Treatment of Idiopathic Hypersomnia
The JZP-258 clinical trial for patients with idiopathic hypersomnia will be conducted in multiple study centers in the
"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).
JZP-258 is an investigational product candidate being evaluated in adult patients for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy and for the treatment of idiopathic hypersomnia. JZP-258 is an oral solution that contains a mixture of oxybate salts, resulting in 90 percent less sodium content than Xyrem® oral solution.
About Idiopathic Hypersomnia
Idiopathic hypersomnia is a sleep disorder characterized by chronic and disabling excessive daytime sleepiness (daytime periods of irrepressible need to sleep or lapse into sleep) that is not caused by other medical, behavioral or psychiatric conditions known to induce excessive sleepiness.1,2,3,4 Symptoms may include prolonged nighttime sleep, long and unrefreshing naps and difficulty waking up from nocturnal sleep or daytime naps.1,2,3,4 Idiopathic hypersomnia is a debilitating illness that can significantly affect social, school and occupational functioning.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to JZP-258 as a potential treatment for idiopathic hypersomnia,
1. 2015 Review article in Chest, by Khan/Trotti et al, "Central Disorders of Hypersomnolence: Focus on the Narcolepsies and Idiopathic Hypersomnia" https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4694150/
2. 2016 Sleep Medicine Review article, by Billiard/Sonka et al, "Idiopathic Hypersomnia " https://www.ncbi.nlm.nih.gov/pubmed/26599679
3. International Classification of Sleep Disorders, Third Edition (ICSD-3): http://www.aasmnet.org/store/product.aspx?pid=849
4. Diagnostic and Statistical Manual of Mental Disorders (DSM-V) p. 368-372 Hypersomnolence Disorder: https://www.psychiatry.org/psychiatrists/practice/dsm
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