Ensemble is an AI-powered digital mental health coach app designed to address the symptoms of MDD or GAD.
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.
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.
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 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.