FDA accepts for priority review supplemental New Drug Application for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia

Submission for this lower-sodium formulation of sodium oxybate (already approved in US for cataplexy or excessive daytime sleepiness in patients with narcolepsyis) is based on RCT which met primary endpoint of clinically meaningful improvements in the Epworth Sleepiness Scale.

Source:

Biospace Inc.