Jazz Pharmaceuticals Announces Positive Top-line Results from Phase 3 Study of Xywav™ 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 Track designation to Xywav for idiopathic hypersomnia, a serious sleep disorder with no approved treatment options

DUBLIN, 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.

Patients 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.

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