FDA approves Xywav to treat cataplexy or excessive daytime sleepiness in patients with narcolepsy.- Jazz Pharma

Jazz Pharmaceuticals plc announced that the FDA approved Xywav (calcium, magnesium, potassium, and sodium oxybate) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

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 – than sodium oxybate at the recommended dosage range of 6 to 9 grams.

The company plans to launch Xywav by the end of the year following Risk Evaluation and Mitigation Strategy (REMS) implementation. Jazz is committed to ensuring access to its medicines and will work to secure the broadest access possible for appropriate patients.

The FDA approval of Xywav is based on a global Phase III double-blind, placebo-controlled, randomized-withdrawal, multicenter study that demonstrated the efficacy and safety of Xywav in the treatment of cataplexy and EDS in patients with narcolepsy. In the study, which enrolled 201 patients, Xywav demonstrated highly statistically significant differences (p<0.0001) in weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo.