USFDAJul 15, 2026, 07:11 AM
Axsome: FDA Accepts NDA for AXS-12 for Cataplexy in Narcolepsy
AI Summary
Axsome Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for AXS-12 (reboxetine). This drug is intended for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027, and currently does not plan to hold an advisory committee meeting for the application.
Key Highlights
- FDA accepted Axsome's New Drug Application (NDA) for AXS-12 (reboxetine).
- AXS-12 is for the treatment of cataplexy in narcolepsy.
- FDA set a PDUFA target action date of May 1, 2027.
- FDA does not currently plan to hold an advisory committee meeting for the application.
- AXS-12 has U.S. FDA Orphan Drug Designation for narcolepsy.
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