Axsome released data for unmet medical need, Alzheimer's Agitation. The therapy may promote easier caregiver duties, so the person with Alzheimer's they are caring for, can remain in their home surroundings, rather than institution. The company hit on one of the two clinical trials completed. The studies were ADVANCE2 and ACCORD2, with the ACCORD2 trial delivering statistical significant results that should lead to a New Drug Application (NDA) and potential FDA approval. The company plans to file the NDA in the second half of 2025. With the completion of these two clinical trials, the company will have three positive studies, results below.
ADVANCE 1 Results:
- Reduction in the CMAI (primary endpoint) vs placebo p=o.010
ACCORD 1 Results:
- Delayed time to relapse p=0.014
- Relapse prevention p=0.018
ACCORD 2 Results:
- Delayed time to relapse p=0.001
- Relapse prevention p=0.001
The safety profile was in line with previous company studies, which could indicate the absence of a black box label. Patent for AXS-05 runs from 2034 to 2043. Thank you for reading.
