FDA accepts for filing NDA for JZP 258 for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.-Jazz Pharma

Jazz Pharmaceuticals plc announced that the FDA accepted for filing with Priority Review the company’s New Drug Application (NDA) seeking marketing approval for JZP 258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

JZP 258 is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or approximately 1,000 to 1,500 milligrams, less sodium than Xyrem (sodium oxybate). Xyrem is the only available product approved to treat both cataplexy and EDS in patients with narcolepsy ages 7 years and older and is the standard of care for treatment of cataplexy. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is July 21, 2020.