Research & Development
Jazz Pharmaceuticals files JZP-258 NDA with FDA for treatment of cataplexy and EDS
26 March 2020 -

Biopharmaceutical company Jazz Pharmaceuticals plc (Nasdaq:JAZZ) said on Wednesday that it has submitted its New Drug Application (NDA) seeking marketing approval of JZP-258 for treating cataplexy under the US Food and Drug Administration's (FDA) Priority Review.

The Prescription Drug User Fee Act (PDUFA) goal date for the FDA's decision is 21 July 2020.

According to the company, JZP-258 is an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. It is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or about 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 aged 7 years and older and is the standard of care for treatment of cataplexy.

Cataplexy, the most specific symptom of narcolepsy, is the sudden, generally brief (