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# Axsome to File NDA on Narcolepsy Drug
- URL: https://www.fdaweb.com/axsome-to-file-nda-on-narcolepsy-drug/
- Published: 2024-11-26T12:00:00.000Z
- Updated: 2026-09-14T14:48:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158267

Axsome Therapeutics says it is planning to submit an NDA based on just-reported Phase 3 trial data on AXS-12 (reboxetine), described as a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, for treating narcolepsy. The data showed that AXS-12 achieved the primary endpoint in the ENCORE Phase 3 trial, demonstrating a statistically significant improvement in the frequency of cataplexy attacks compared to placebo, according to the company. Regarding its safety, AXS-12 was said said to have been shown to be well tolerated during long-term dosing with a safety profile consistent with that observed in previously completed trials.

AXS-12 is thought to modulate noradrenergic activity to maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition, according to the company. AXS-12 was previously granted an orphan drug designation for treating narcolepsy.