Axsome Therapeutics’ Auvelity expanded its label to include treating agitation in Alzheimer’s disease patients. It’s just the second FDA-approved drug for this indication, and Axsome’s pill has a safety advantage.
One Phase 3 test of Auvelity met its main goal in Alzheimer’s agitation while the drug’s other pivotal trial showed numerical improvement that fell short of statistical significance. Axsome Therapeutics aims to offer an alternative to Rexulti, a Lundbeck and Otsuka Pharmaceutical product that is the only FDA-approved Alzheimer’s agitation drug.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
The FDA has approved Axsome Therapeutics drug Auvelity as a treatment for major depressive disorder in adults. The regulatory decision makes the twice-daily pill the first new oral drug approved to address a novel depression target in more than 60 years.