Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder GlobeNewswire•January 7, 2019
Demonstrated statistically significant improvement in MADRS scores compared to active comparator (p<0.001 on primary endpoint)
Rapid improvement in depressive symptoms demonstrating statistically significant superiority over active comparator within the first week (p=0.045 on CGI-I)
Improvement with AXS-05 versus active comparator seen on multiple secondary endpoints, including remission in 47% of AXS-05 patients versus 16% of active comparator patients (p=0.004)
Data support ongoing development of AXS-05 in treatment resistant depression and further development in MDD
Potentially first-in-class, oral NMDA receptor antagonist with multimodal activity for the treatment of depression