The FDA Accepts NDA for Oxybate Mixed Salts for Excessive Daytime Sleepiness

The Food and Drug Administration (FDA) accepted a new drug application (NDA) for oxybate mixed salts (JZP-258, Jazz Pharmaceuticals, Philadelphia, PA). The oxybate mixed salts is an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDS) in individuals age 7 years or more with narcolepsy. The oxybate mixed salts is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or approximately 1,000 mg to 1,500 mg, less sodium than Xyrem (sodium oxybate). Xyrem is the only available product approved to treat both cataplexy and EDS in individuals with narcolepsy age 7 years or more 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.

"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," said Robert Iannone, MD, MSCE, executive vice president, research and development of Jazz Pharmaceuticals. "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."

Oxybate mixed salts has the same oxybate concentration as Xyrem and includes other cations, such as calcium, magnesium, and potassium. The exact mechanism of action of oxybate mixed salts is not fully understood, it is hypothesized that the therapeutic effects of oxybate mixed salts on sleep/wake symptoms are mediated through modulation of GABA during sleep.