JAZZ - Jazz Pharma's Xywav shows clinical benefit in excessive sleepiness disorder

Jazz Pharmaceuticals (JAZZ) up 4% in premarket, on top-line results from the Phase 3 withdrawal study that is evaluating Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia.The study included 115 patients with primary endpoint of Epworth Sleepiness Scale ((ESS)), and key secondary endpoints of Patient Global Impression of Change ((PGIc)) and Idiopathic Hypersomnia Severity Scale ((IHSS))Patients treated with Xywav showed clinically meaningful maintenance of efficacy for ESS, PGIc and IHSS, and highly statistically significant worsening in patients administered placebo was observed, compared with Xywav for ESS and IHSS.No new safety signals observed in this population.Jazz will submit the Phase 3 study data for presentation at an upcoming medical meeting. Supplemental marketing application to the FDA is up next, expected as early as Q1 of 2021. Recently, Xywav nabbed U.S. fast track review.Xywav was approved in July by the FDA for the treatment of cataplexy or excessive daytime sleepiness in patients 7

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Jazz Pharma's Xywav shows clinical benefit in excessive sleepiness disorder