FDA grants orphan drug designation for oral narcolepsy treatment
The FDA granted orphan drug exclusivity for JZP258, an oral solution for the treatment of narcolepsy symptoms, according to the agent’s manufacturer. JZP258 (Jazz Pharmaceuticals plc), also known as Xywav, is a low-sodium oxybate aimed at correcting cataplexy and excessive daytime sleepiness in patients aged as young as 7 years, as well as narcolepsy in adults.