Jazz Pharma Builds Case for Xywav

DUBLIN – Jazz Pharmaceuticals continues to make the case for Xywav™ (calcium, magnesium, potassium and sodium oxybates), an oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Publication of a global phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study confirmed that Xywav contains 92 percent less sodium per nightly dose than sodium oxybate. 

In the trial, Xywav achieved primary and key secondary endpoints demonstrating highly statistically significant differences (p<0.0001) in median change in weekly number of cataplexy attacks and Epworth Sleepiness Scale (ESS) scores compared to placebo. Results of the study were previously presented in an oral presentation at World Sleep 2019. Results were published in SLEEP, the peer-reviewed, international journal of the Sleep Research Society.

“This publication reinforces the option Xywav provides for those living with cataplexy or EDS associated with narcolepsy,” said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. “Xywav was approved in July by the FDA as a new treatment option indicated for both cataplexy and EDS in people living with narcolepsy and I am proud to be part of the organization that developed this groundbreaking therapy for people living with this debilitating neurological disorder.”

This Phase 3 study served as the basis of the U.S. Food and Drug Administration approval of Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.1,2 Xywav is an oxybate product with a unique composition of cations resulting in 92 percent less sodium – or approximately 1,000 to 1,500 mg/night less – than sodium oxybate at the recommended dosage range of 6 to 9 grams.2 Meaningfully lowering the level of sodium ingested by patients taking oxybate therapy may help patients align with American Heart Association recommended levels of daily sodium intake.

Click Here for the full Jazz Pharma news release with complete citations.   

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