AXS-05 Phase 3 Alzheimer's Agitation Results

Today, Axsome Therapeutics released top line results from their ACCORD, phase 3 Alzheimer's Agitation study with drug AXS-05. The results met both primary and secondary efficacy endpoints below.

 

  -  Delayed time to agitation relapse vs. placebo p=0.014

  -  Prevented relapse of agitation vs. placebo p=0.018

Other important endpoints:

  -  Alzheimer's agitation, CMAI total score, open label p=0.001

These results bode well with the previously completed ADVANCE-1 phase 2/3 study released in 2020. Axsome plans to take these results to the FDA, with the intent to file a supplemental New Drug Application, (sNDA). Alzheimer's Agitation is an unmet medical need, with no treatments currently approved. With AXS-05, the likelihood for patients remaining in their homes becomes more favorable, easier on caregivers, reducing overburdened nursing care facilities. We previously wrote about this unmet need here Agitation in Alzheimer's Disease -An Unmet Need Part 2. Chart of Axsome below. Thank you for reading.