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Jazz Pharmaceuticals obtains FDA blessing for Xywav


Patients with cataplexy or excessive daytime sleepiness will soon have a new treatment available.

The Food and Drug Administration has cleared Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution. The product is indicated for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.

"We have been working for nearly a decade to develop Xywav, a unique oxybate product with a significant reduction in sodium. We are proud to advance the science behind our sleep research program in order to continue making a difference for people living with narcolepsy," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Jazz is committed to addressing unmet needs in sleep medicine, which includes our innovative and long-standing oxybate program."

“Based on the efficacy demonstrated in the clinical program, the approval of Xywav is important for people living with cataplexy or EDS associated with narcolepsy. Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. This may help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association," said Richard Bogan, associate clinical professor at the University of South Carolina School of Medicine, a medical officer at SleepMed in Columbia, S.C. and lead investigator of the Phase 3 study. "The average American consumes too much sodium. Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke, and other cardiovascular disease."

The company plans to launch Xywav by the end of the year.

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