FDA Neurology Digest: August 2026
β’ The FDA has approved Oveporexton (brand name Orzeyful), developed by Takeda, for the treatment of narcolepsy type 1 in adults. β’ As the first drug to directly restore orexin signaling, the twice-daily tablet demonstrated improvements in daytime sleepiness, cataplexy, sleep paralysis, and hallucinations across two clinical trials. β’ The approval follows the drug's receipt of FDA Breakthrough Therapy designation and Priority Review, addressing the core biological deficit of the disorder.
medscape.com