FDA approves Xywav for idiopathic hypersomnia in adults

The FDA approved a new indication for Xywav for the management of idiopathic hypersomnia in adults, according to a press release from the agency.

Idiopathic hypersomnia is an uncommon chronic sleep disorder that causes individuals to experience excessive sleepiness during the day, even after a good night’s sleep, according to the press release. Xywav oral solution (calcium, magnesium, potassium and sodium oxybates; Jazz Pharmaceuticals) already received FDA approval for the treatment of cataplexy or excessive daytime sleepiness among patients aged 7 years or older with narcolepsy. The FDA granted Xywav fast track and priority review designations, according to the press release; the agent also received orphan drug designation.

Researchers examined the effectiveness of Xywav in a double-blind, placebo-controlled, randomized-withdrawal study of 154 participants aged 19 to 75 years with idiopathic hypersomnia. found that patients randomly assigned to switch from Xywav to placebo had worsening on measures of sleepiness and symptoms of idiopathic hypersomnia compared with patients randomly assigned to continue treatment with Xywav, according to the press release.

The most common adverse events related to treatment included nausea (21.4%), headache (16.2%), dizziness (11.7%), anxiety (10.4%) and vomiting (10.4%). Xywav also has a boxed warning regarding central nervous system depression and abuse and misuse, according to the press release, and is to be prescribed and dispensed under the Risk Evaluation and Mitigation Strategy program.

“A novel indication for Xywav is significant as the FDA has never granted an approval for idiopathic hypersomnia,” Eric Bastings, MD, deputy director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Idiopathic hypersomnia is a life-long condition and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking and in effectively managing this debilitating disorder.”

• Reference:
• FDA. FDA grants first of its kind indication for chronic sleep disorder treatment. Available at: https://www.fda.gov/news-events/press-announcements/fda-grants-first-its-kind-indication-chronic-sleep-disorder-treatment. Accessed Aug 13, 2021.