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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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