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Home » 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.
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