AXS-05 consists of dextromethorphan, an NMDA receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor.
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The approval was based on the ASPIRE I and II trials that compared the efficacy and safety of esketamine, an N-methyl-D-aspartate receptor antagonist, to placebo in 449 adults with moderate to severe MDD who had active suicidal ideation and intent.
Ensemble is an AI-powered digital mental health coach app designed to address the symptoms of MDD or GAD.