Shots:
- The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease
- Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders
- In ADVANCE-1, Auvelity improved agitation symptoms per CMAI total score (2EP) & key mADCS-CGIC responses at Wk. 5 vs PBO, while in ACCORD-2, continued treatment significantly delayed relapse of agitation symptoms vs switching to PBO
Ref: Axsome| Image: Axsome | Press Release
Related News: Axsome Therapeutics Acquires Global Rights to Balipodect from Takeda
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