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Pharmaceuticals / Submissions and Approvals

Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05

May 12, 2017

Axsome received a fast track designation from the FDA for AXS-05, developed for the treatment of agitation in patients with Alzheimer’s disease.

The drug is a combination of bupropion and dextromethorphan. Bupropion increases the bioavailability of dextromethorphan — an inhibitor of the serotonin and norepinephrine transporters.

Axsome Therapeutics previously received IND clearance from the FDA for a Phase II/III trial of AXS-05.

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