FDA accepts JZP-258 NDA for priority review in cataplexy and EDA

The US Food and Drug Administration has accepted for filing with Priority Review the New Drug Application (NDA) seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDA) in patients seven years of age and older with narcolepsy.

The NDA was filed with the agency late January by Ireland-incorporated Jazz Pharmaceuticals (Nasdaq: JAZZ), which said it had redeemed its priority review voucher for the submission. The firm’s share rose 5% in after-hours trading on Wednesday.

JZP-258 is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or around1,000 to 1,500 milligrams, less sodium than Xyrem (sodium oxybate). Xyrem is the only available product approved to treat both cataplexy and EDA in patients with narcolepsy ages seven years and older and is the standard of care for treatment of cataplexy.