Posted by Michael Wonder on 26 Mar 2020
Jazz Pharmaceuticals announces FDA acceptance of new drug application for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy
25 March 2020 - Jazz Pharmaceuticals today announced that the U.S. FDA accepted for filing with priority review the company's new drug application seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness 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 goal date for an FDA decision is 21 July 2020.
