FDA Neurology Digest: August 2026
• The FDA has approved Oveporexton (brand name Orzeyful), developed by Takeda, for the treatment of narcolepsy type 1 in adults. • 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. • 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