Supplemental new drug application for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia submitted to FDA

The submission is based on a Phase 3 multi-national, double-blind, multicenter, placebo-controlled, randomised withdrawal study evaluating the efficacy and safety of Xywav for the treatment of idiopathic hypersomnia in adult patients.

Source:

Biospace Inc.