FDA Approves Drug for Cataplexy, Excessive Daytime Sleepiness Associated With Narcolepsy

The US Food and Drug Administration (FDA) has approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution to treat cataplexy or excessive daytime sleepiness associated with narcolepsy among patients aged 7 years or older.

Xywav is the first option for this indication approved by the FDA in more than 15 years. Notably, it contains 92% less sodium than sodium oxybate, a current standard-of-care option, at a dosage range of 6 to 9 g.

“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 lead investigator Richard K. Bogan, MD, associate clinical professor at the University of South Carolina School of Medicine, in a press release.

Headache, dizziness, nausea, parasomnia, decreased appetite, hyperhidrosis, diarrhea, anxiety, and vomiting were the most common adverse reactions among adults taking Xywav. These reactions occurred in 5% or fewer adults taking Xywav.

The labeling of Xywav contains a boxed warning, stating that Xywav is a central nervous system depressant. Because of its potential for misuse and abuse, Xywav is only available through a Risk Evaluation and Mitigation Strategy (REMS) called the Xywav and Xyrem REMS Program.

—Christina Vogt

Reference:
Jazz Pharmaceuticals announces U.S. FDA approval of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy. News release. Jazz Pharmaceuticals; July 22, 2020. Accessed July 22, 2020. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-xywavtm-calcium