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Axsome Draws FDA Deficiency Letter Over Depression Drug

August 11, 2021

Axsome Therapeutics has received a deficiency letter from the FDA for its investigational neurological drug AXS-05 (dextromethorphan-bupropion) for major depressive disorder.

The FDA, which granted AXS-05 Priority Review and Breakthrough Therapy designations for this indication, uses deficiency letters to communicate gaps in information identified during a drug review.

“We are attempting to learn the nature of these deficiencies with the goal of addressing them; however, this development may lead to a delay in the potential approval of AXS-05,” said Herriot Tabuteau, CEO of the New York City-based biopharmaceutical firm.

The July 30 letter from the FDA “did not state what the deficiencies are,” Axsome said, adding that the agency has not given the company any additional information about that since then.

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