Posted by Michael Wonder on 15 Feb 2017
Axsome Therapeutics receives FDA fast track designation for AXS-05 for treatment resistant depression
14 February 2017 - Axsome Therapeutics has received fast track designation from the U.S. FDA for AXS-05 for treatment resistant depression.
AXS-05 is currently being evaluated in the STRIDE-1 study, a Phase 3, randomised, double-blind, active-controlled trial to assess the efficacy and safety of AXS-05 in the treatment of treatment-resistant depression.
AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan.
