Auvelity

Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

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 Frank Vinluan

BioPharma, Pharma

Better late than never? Axsome depression drug is approved a year after FDA delay

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.

By Frank Vinluan