www.fdanews.com/articles/198191-jazz-pharmaceuticals-xywav-approved-for-narcolepsy
Jazz Pharmaceuticals’ Xywav Approved for Narcolepsy
July 24, 2020
The FDA has approved Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution for the treatment of cataplexy — a sudden, brief loss of voluntary muscle tone — or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
The approval was based on positive results from a phase 3 clinical trial in which Xywav demonstrated statistically significant differences in the weekly number of cataplexy attacks and excessive sleepiness compared to a placebo.
The FDA required a boxed warning for Xywav because of its potential for misuse and abuse.