AXS-05 consists of dextromethorphan, an NMDA receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor.
Ensemble is an AI-powered digital mental health coach app designed to address the symptoms of MDD or GAD.
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.
The applications are supported by positive results from a double-masked, 4-week, pivotal phase 2/3 clinical trial that compared the effects of tasimelteon to placebo in 25 patients with SMS.
The FDA has approved Somryst™ (Pear Therapeutics), a prescription digital therapeutic (PDT) intended for the treatment of patients 22 years of age and older with chronic insomnia.