The US Food and Drug Administration (FDA) accepted for filing with Priority Review the Jazz Pharmaceuticals plc’s New Drug Application (NDA) seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
JZP-258 is a oxybate product candidate with a composition of cations resulting in 92%, or approximately 1,000 to 1,500 mg, less sodium than Xyrem (sodium oxybate).
The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is July 21, 2020.
“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,” says Robert Iannone, MD, MSCE, executive vice president, research and development of Jazz Pharmaceuticals, in a release. “Given the broad scientific consensus that reducing daily sodium consumption is associated with clinically meaningful reductions in blood pressure and cardiovascular disease risk, we believe that JZP-258 has the potential to be an important treatment option for patients living with the life-long condition of narcolepsy. Narcolepsy patients are known to be at increased risk of comorbidities, including obesity, hypertension, diabetes, and dyslipidemia.”