360° Insights: Axsome's AXS-05

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Axsome’s AXS-05 is a fixed-dose combination of dextromethorphan and bupropion that is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). Although bupropion is an antidepressant, Axsome has stated that the primary reason for including it in the combination product is to increase the bioavailability of dextromethorphan.

If approved, AXS-05 will be the second FDA-approved NMDA receptor antagonist for the treatment of MDD, after Janssen’s Spravato (esketamine).