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Axsome Therapeutics Begins Phase 3 Trial Of AXS-05 In Alzheimer's Disease Agitation

Axsome Therapeutics Inc. (AXSM) said that it has initiated ACCORD phase 3 trial of AXS-05 in alzheimer's disease agitation. It expects topline results from the trial will be available in the second half of 2022.

AXS-05--45 mg dextromethorphan-105 mg bupropion modulated delivery tablet-- is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.

ACCORD is being conducted using a randomized-withdrawal design, in which all patients are first treated with open-label AXS-05, with the patients experiencing a treatment response being subsequently randomized in a double-blind fashion to continued treatment with AXS-05 or to switch to placebo.

Patients completing the ACCORD trial will be eligible to enter an open-label safety extension trial. Initiation of the safety extension trial is expected imminently.

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