Axsome's AXS-05 Receives US FDA's Breakthrough Therapy Designation for the Treatment of Alzheimer's Disease Agitation
Shots:
- The US FDA has granted the BTD for AXS-05 to treat AD agitation. The designation offers potential for expedited development and review
- The designation was based on P-II/III ADVANCE-1 study assessing AXS-05- bupropion vs PBO in 366 patients with AD. The study demonstrated substantial improvement in agitation; mean reduction from baseline in the CMAI total score @5wks. (15.4 vs 11.5 points); superior to bupropion on the CMAI total score and was well tolerated
- AXS-05 is a novel- oral- investigational NMDA receptor antagonist with multimodal activity has now received two BTD for separate CNS indications
Ref: GlobeNewswire | Image: Specialty Pharma Journal
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