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# Priority Review for Axsome AXS-05 Depression Drug
- URL: https://www.fdaweb.com/priority-review-for-axsome-axs-05-depression-drug/
- Published: 2021-04-27T12:00:00.000Z
- Updated: 2026-09-14T16:56:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149202

FDA has accepted for filing and granted priority review to Axsome Therapeutics’ NDA for its AXS-05 (dextromethorphan bupropion) for treating major depressive disorder (MDD). The company says AXS-05 is a novel, oral, investigative NMDA receptor antagonist with multimodal activity. FDA has set 8/22 as the PDUFA action date for its review.

The agency previously granted AXS-05 breakthrough therapy designation 3/2019 for treating MDD. It also granted a breakthrough therapy designation 6/2020 for treating Alzheimer’s disease.

The company says the NDA is supported by results from two trials in patients with a confirmed diagnosis of moderate to severe MDD that demonstrated statistically significant improvements in depressive symptoms with AXS-05 compared to placebo or active controls.