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FDA Press Releases·

FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms

The U.S. Food and Drug Administration today approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder — addressing the full range of symptoms that define the condition — and the first to work by directly targeting the loss of orexin signaling that causes the disease. “For too long, people with narcolepsy type 1 have had to manage a complex, lifelong neuropsychiatric condition with treatments that only address pieces of it,” said Tiffany R. Farchione, M.D., Director of the Division of Psychiatry within the FDA’s Center for Drug Evaluation and Research. “This new drug is the fir...