Axsome to lean on totality of data in Alzheimer’s agitation submission  

Only one drug is approved to treat agitation in Alzheimer’s patients. Axsome hopes to make AXS-05 the second, despite mixed results from its latest two Phase III trials in the indication.

Axsome Therapeutics Inc. (NASDAQ:AXSM) believes the totality of the evidence in its Phase III program supports an NDA submission next half. Although AXS-05 did not show statistical significance at improving disease scores in the ADVANCE-2 study, it has now led to significant improvements in the ADVANCE-1, ACCORD-1 and ACCORD-2 trials. ADVANCE-2 and ACCORD-2 delivered results on Dec. 30...