AXS-05 consists of dextromethorphan, an NMDA receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor.
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.
Alzheimer's Disease and Dementia
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease agitation.
Ensemble is an AI-powered digital mental health coach app designed to address the symptoms of MDD or GAD.
The phase 3 SPR1NT trial is an ongoing open-label, single-arm study evaluating onasemnogene in presymptomatic patients (≤6 weeks of age) with a genetic diagnosis of SMA and 2 or 3 copies of survival motor neuron 2 gene.