Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) reported the Food and Drug Administration’s acceptance of its New Drug Application for JZP-258.
The NDA in questions was for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients sevem 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 seven years and older and is the standard of care for treatment of cataplexy. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is July 21, 2020.
Said Executive Vice-President Robert Iannone, "We developed JZP-258 to be a safer and long-term treatment option for patients. JZP-258 represents between 1,000 and 1,500 milligrams daily reduction of sodium for patients currently treated with Xyrem, depending on the dose."
Narcolepsy is a chronic, debilitating neurological disorder characterized by EDS and the inability to regulate sleep-wake cycles normally.
It affects an estimated one in 2,000 people in the United States, with symptoms typically appearing in childhood or adolescence. It is estimated that more than 50% of people with narcolepsy have not been diagnosed.
JAZZ shares acquired $2.46, or 2.6%,to $98.10
