USFDAJul 15, 2026, 07:01 AM
Axsome FDA Accepts AXS-12 NDA for Narcolepsy; PDUFA May 1, 2027
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). AXS-12 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 New Drug Application (NDA) for AXS-12 for cataplexy in narcolepsy.
- PDUFA target action date set for May 1, 2027.
- FDA does not currently plan an advisory committee meeting for the application.
- AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor.
- AXS-12 has U.S. FDA Orphan Drug Designation for narcolepsy.
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