FDA Approves Novel Therapy for Cataplexy, Excessive Daytime Sleepiness Associated With Narcolepsy

July 23, 2020

This week, the FDA approved Jazz Pharmaceuticals’ XywavTM (calcium, magnesium, potassium, and sodium oxybates), an oral solution for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy.

This week, the FDA approved Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates), an oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years and older with narcolepsy.

The approval comes after results of a global phase 3 double-blind, placebo-controlled, multicenter study demonstrated safety and statistically significant differences (P < .0001) in the weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared with placebo. Moreover, the novel therapy, previously called JZP-258, adds another viable option for the treatment of cataplexy and EDS in patients with narcolepsy, which was previously only treated with sodium oxybate.

"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," said Richard K. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine and lead investigator of the phase 3 study.

Although designated as the standard of care within treatment of cataplexy and EDS in patients with narcolepsy, sodium oxybate’s high sodium content can further amplify risks of comorbidities such as hypertension and cardiovascular disease, which are already prominent in those with the condition. "This may help patients taking sodium oxybate better align with daily sodium intake recommendations, including those by the American Heart Association,” said Bogan.

Through Xywav, patients with narcolepsy experiencing cataplexy or EDS are now provided with an alternative that has 92% less sodium per nightly dose than sodium oxybate at the recommended dosage range of 6 to 9 grams.

"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 chief executive officer of Jazz Pharmaceuticals.

The announcement additionally highlights that the novel treatment will contain a boxed warning as a central nervous system depressant due to its potential for abuse and misuse and will only be available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Xywav and Xyrem REMS Program.

Jazz Pharmaceuticals plans to launch Xywav by the end of the year following the REMS implementation.

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 23, 2020. http://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-xywavtm-calcium