FDA panel reviews psychedelic drug MDMA for the first time

A panel of advisers to the U.S. Food and Drug Administration were set to vote on Tuesday on whether a therapy based on psychedelic drug MDMA should be recommended for patients with post-traumatic stress disorder.

The treatment, a capsule form of MDMA made by public-benefit corporation Lykos Therapeutics, is intended to be administered to patients in combination with talk therapy sessions by a licensed mental health provider. The FDA, during the panel meeting, said there was a “striking lack” of documentation of abuse related adverse events, which may limit the agency’s ability to explain the effects of MDMA or determine its abuse liability.

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