Jazz Pharma Publishes Full Data Set From Phase 3 Trial In Adults With Idiopathic Hypersomnia

(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) said the positive data from the phase 3 double-blind, randomized withdrawal study of Xywav oral solution for the treatment of adults with idiopathic hypersomnia were published online in The Lancet Neurology. In August 2021, Xywav became the only drug approved by the FDA for patients with idiopathic hypersomnia. Xywav was made commercially available in November 2021.

In the study, treatment with Xywav resulted in clinically meaningful improvement in idiopathic hypersomnia symptoms, including excessive daytime sleepiness, sleep inertia and prolonged sleep duration. Overall safety profile was consistent with other oxybate studies.