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• AXS-05 vs PBO was assessed under ACCORD-2 in AD patients (n=167) who rolled over from OLE (n=295) to 26wks. double-blind period and under ADVANCE-2 in AD patients (n=408) with agitation for 5wks.
• ACCORD-2:- OLE period: CMAI score reduced by 20.4 points (46%), clinical response (≥30% reduction) in 69%, AD agitation improvement by mADCS-CGIC in 78% at wk.6 plus by PGI-C in 71% (wk.4) & 78% (wk.8); 70% entered double-blind phase. Double-blind phase: delayed agitation relapse, reducing risk by 3.6-fold (8.4% vs 28.6%); prevented worsening of agitation severity (20.5% vs 41.7%) & overall AD severity (13.3% vs 39.3%)
• ADVANCE-2:- 1EP (CMAI score reduction: 13.8 vs 12.6 points) was insignificant but all EPs favored AXS-05. NDA is planned in H2’25 for the same

Ref: Axsome Therapeutics | Image: Axsome Therapeutics

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