(RTTNews) - 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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