Axsome Therapeutics Receives FDA Fast Track for Depression Treatment

Axsome Therapeutics receives FDA Fast Track designation for AXS-05 for treatment resistant depression.

Axsome Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AXS-05 for treatment resistant depression (TRD). AXS-05 is currently being evaluated in the STRIDE-1 study, a Phase 3, randomized, double-blind, active-controlled trial to assess the efficacy and safety of AXS-05 in the treatment of TRD.

“At least 3 million individuals in the U.S. alone are estimated to be living with treatment resistant depression, a condition associated with potentially devastating consequences,” said Herriot Tabuteau, M.D., chief executive officer of Axsome. “The decision by the FDA to grant Fast Track status for AXS-05 for treatment resistant depression underscores the limited treatment options for this serious condition and the potential for AXS-05 to address this unmet medical need. We look forward to continued progress with our ongoing STRIDE-1 trial of AXS-05 in treatment resistant depression.”

The FDA’s Fast Track designation program is designed to aid in the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions. In order to receive Fast Track designation, a product must also demonstrate the potential to address an unmet medical need. Fast Track designation provides greater access to, and more frequent communication with, the FDA throughout the entire drug development and review process, with the goal of getting important new drugs to patients more rapidly.

It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where the FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, Fast Track designated products are eligible for Priority Review at the time of NDA submission.

About AXS-05

AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the FDA.

(Source: Globe Newswire)