Jazz NDA for Daytime Sleepiness Approved

FDA has approved a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy. Approval was based on data from a global Phase 3 double-blind, placebo-controlled study in 201 patients, which showed that the drug demonstrated statistically significant differences in weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo, the company says.

Xywav’s labeling carries warnings about its high sodium content, including a Boxed Warning as a central nervous system depressant, and for its potential for abuse and misuse. Because of the risks of CNS depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategies program, Jazz says.