Jazz Pharmaceuticals plc filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) on April 27, 2018 seeking revised labeling for Xyrem (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients.
“Narcolepsy is a life-long disorder for which no cure has been identified. Its symptoms commonly begin during childhood, yet there are no FDA approved treatments for pediatric narcolepsy patients that address cataplexy,” says Jed Black, MD, senior vice president, sleep and CNS medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine, in a release. “Jazz is committed to sleep medicine innovation, and our continued research and development of Xyrem is an important part of addressing unmet needs within the sleep patient community.”
Xyrem oral solution is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness in narcolepsy. Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program. Xyrem was first approved in the United States in 2002, based on clinical trial data in adults. The current United States Package Insert for Xyrem indicates that safety and effectiveness in pediatric patients have not been established.