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Axsome's AXS-05 Receives US FDA's Breakthrough Therapy Designation for the Treatment of Alzheimer's Disease Agitation

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Axsome's AXS-05 Receives US FDA's Breakthrough Therapy Designation for the Treatment of Alzheimer's Disease Agitation

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

Click here to­ read the full press release 

Tuba

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on connect@pharmashots.com

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