JAZZ - Jazz Pharma Files for FDA Approval of a New Narcolepsy Drug
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has submitted an application for Food and Drug Administration (FDA) approval of JZP-258, a new drug for cataplexy and excessive daytime sleepiness (EDS) in patients with narcolepsy age 7 and up. To speed along an FDA review of JZP-258, the company is redeeming a priority review voucher that shortens the FDA's decision timeline from 10 months to six months.
Image source: Getty Images.
The loss of muscle tone while conscious, or cataplexy, and EDS are two of the five primary symptoms of narcolepsy. EDS affects every patient, while roughly 70% of patients experience cataplexy. If approved, JZP-258 could become an important treatment option, particularly in patients on a sodium-restricted diet due to cardiovascular disease or hypertension.