Axsome Phase III program of AXS-05 in Alzheimer’s disease agitation

31 December 2024

US CNS specialist Axsome Therapeutics (Nasdaq: AXSM) yesterday announced the completion of its Phase III clinical program evaluating AXS-05 (dextromethorphan-bupropion), a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor, in Alzheimer’s disease agitation, and results of the ACCORD-2, ADVANCE-2, and long-term safety trials in this indication.

The firm’s shares dropped as much as 8% but recovered partially to close down just 2.2% lower at $84.78 on Monday.

In August 2022, AXS-05 was approved in the USA for the treatment of depression under the trade name Auvelity and moving into Alzheimer’s agitation would be an important expansion. Chris Howerton, an analyst at Jefferies, previously predicted the drug could generate as much as $1.8 billion in peak yearly sales.

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