Axsome Alzheimer’s agitation drug shines in phase 3 trial

Nov. 28, 2022

New York-based biopharma Axsome Therapeutics announced this week that its investigational NMDA receptor antagonist showed promising results in its recent phase 3 trial by significantly delaying relapse time of agitation in patients with Alzheimer’s disease.

The ACCORD (Assessing Clinical Outcomes in Alzheimer’s Disease Agitation) trial included 178 patients and compared the drug candidate AXS-05 to a placebo. AXS-05 not only met its primary endpoint of delaying agitation relapse time but also succeeded in its secondary endpoint of relapse prevention. 

Axsome reported that patients treated with AXS-05 experienced “rapid, substantial, and statistically, a significant improvement compared to baseline in agitation symptoms,” for which there are no FDA-approved treatments.  

AXS-05, Axsome’s lead candidate and potential blockbuster, was approved under the brand name Auvelity for the treatment of major depressive disorder back in August — a year after its initial PDUFA date.

The drug was granted Breakthrough Therapy designation for the treatment of Alzheimer's disease agitation by the FDA in June 2020.