Jazz Pharmaceuticals completes rolling submission of supplemental NDA for Xywav oral solution for idiopathic hypersomnia.

Jazz Pharmaceuticals plc announced the completion of the rolling submission for the supplemental New Drug Application (sNDA) to the FDA seeking marketing approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of adult patients with idiopathic hypersomnia. If approved, Xywav will be the first and only approved treatment in the U.S. for adults with idiopathic hypersomnia. Xywav received Fast Track designation by the FDA in September 2020 for the treatment of idiopathic hypersomnia. Jazz was granted rolling submission by FDA for this sNDA in December 2020, permitting the submission of portions of the proposed application as they were completed. Idiopathic hypersomnia is a debilitating illness characterized by chronic and disabling excessive daytime sleepiness that can significantly affect social, school and occupational functioning. Symptoms may also include prolonged, non-restorative nighttime sleep, long and unrefreshing naps and prolonged difficulty waking (sleep inertia), with frequent reentries into sleep, confusion, and irritability. Insurance claims data in the U.S. suggest that the diagnosed prevalence of idiopathic hypersomnia is more than 37,000 adult patients; however, many more are likely living with undiagnosed idiopathic hypersomnia..