Jazz Pharmaceuticals has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking revised labeling for Xyrem (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy and EDS 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," said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. "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."