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Jazz Pharmaceuticals Announces Positive Top-line Results from Phase 3 Study of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution in Adult Patients with Idiopathic Hypersomnia
Clinically meaningful and highly statistically significant results for primary and both key secondary endpoints U.S. Food and Drug Administration grants Fast
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Clinically meaningful and highly statistically significant results for primary and both key secondary endpoints\n U.S. Food and Drug Administration grants Fast Track designation to Xywav for idiopathic hypersomnia, a serious sleep disorder with no approved treatment options\n\n\nDUBLIN, Oct. 8, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive top-line results from the Phase 3 double-blind, multicenter, placebo-controlled, randomized withdrawal study evaluating the efficacy and safety of an investigational use of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia. \nPatients entering the study had excessive daytime sleepiness typical of the idiopathic hypersomnia population. All patients were treated with Xywav during the open-label titration period and clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) were observed.\nThe primary endpoint of ESS and the key secondary endpoints of Patient Global Impression of Change (PGIc) and Idiopathic Hypersomnia Severity Scale (IHSS) were measured during the randomized withdrawal portion of the trial, which included 115 patients. Those who were administered Xywav showed clinically meaningful maintenance of efficacy for ESS, PGIc and IHSS, and there were highly statistically significant worsenings in patients administered placebo compared with Xywav for ESS (p-value","length":1620,"tagName":"div"}]