Jan 22 2020
Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy
h in News
DUBLIN, Jan. 22, 2020 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration on January 21, 2020 seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The company redeemed its priority review voucher for the NDA submission.
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). This substantial reduction could allow patients to achieve a daily sodium intake target of 2,300 mg, and ideally 1,500 mg, as set by the American Heart Association.