Jazz Pharma files NDA for JZP-258 for cataplexy and excessive daytime sleepiness

Ireland-incorporated Jazz Pharmaceuticals (Nasdaq: JAZZ) today revealed it has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.

The company said it 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 2,300mg, and ideally 1,500mg, as set by the American Heart Association.1

"Narcolepsy is a chronic disorder, for which lifelong therapy may be clinically indicated, and is associated with an increased risk of co-morbid conditions, including hypertension and cardiovascular disease," said Dr Robert Iannone, executive vice president, R&D at Jazz Pharmaceuticals, adding: "Jazz is committed to addressing unmet needs in sleep medicine, which includes working for nearly a decade to develop a novel oxybate formulation with a significant reduction in sodium."