The P-III (ACCORD) trial evaluates AXS-05 vs PBO in a ratio (1:1) in 178 patients with AD agitation. 108 were randomized to continue on AXS-05 or switch to PBO
The trial met the 1EPs & 2EPs i.e., significantly delayed time to relapse & prevented relapse (7.5% vs 25.9%), an improvement over baseline in agitation symptoms, improvement in agitation (66.3% @2wk.) and 86.3% @5wk. as assessed using mADCS-CGIC; 68% & 89% by PGI-C scale
Mean reduction from baseline in CMAI total score @1/2/5wk. was 6.7/11.0/20.6 points & clinical response (21.8%/40.4%/70.0%), improvement in caregiver distress, caregiver burden, QoL & depressive symptoms after being treated with open-label AXS-05 @4 & 8wk., rate of AEs (28.3% vs 22.2%), AEs leads to treatment discontinuations (0% vs 1.9%)
Ref: axsome | Image: axsome
