AXS-05 Phase 3 Results for Alzheimer's Agitation

Axsome released phase 3 results today from their ongoing clinical trial evaluating AXS-05 for agitation associated with Alzheimer's disease. Currently there is no drug approved for this unmet need. The results below were good, with a rapid and substantial effect. The complete press release is at Axsome.com.

• Cohen Mansfield (CMAI) total score at 5 weeks, p=0.010 versus placebo
• Week 3 compared to placebo p=0.007
• Well tolerated and not associated with cognitive impairment or sedation

AXS-07 Phase 3 for Acute Migraine (Intercept)

This phase 3 clinical trial was called Intercept, the second phase 3 clinical trial completed after the Momentum phase 3 trial for patients experiencing an acute migraine. Below are the highlights of the successful trial, and the Intercept Phase 3.

• Pain Freedom 2 hours after dosing achieved by 32.6% of patients
• Pain Freedom at 24 hours after dosing in 22.7% of patients
• Freedom from most bothersome symptoms achieved in 43.9% of patients
• Rescue medication was used by 15.3% of patients at 24 hours

Based on these results, I expect the company to prepare and file an NDA (new drug application) prior to year end. Thank you for reading.