Axsome Therapeutics receives FDA fast track designation for AXS-05 for Alzheimer’s disease agitation

Axsome Therapeutics

8 May 2017 - Axsome Therapeutics received fast track designation from the U.S. FDA for AXS-05 for the treatment of agitation in patients with Alzheimer’s disease. 

There are currently no approved treatments for this condition. Axsome previously received Investigational new drug application clearance from the FDA to proceed with a Phase 2/3 trial of AXS-05 in this indication.

Read Axsome Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission , Fast track