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FDA panel snubs Lykos’ MDMA therapy, not psychedelics generally

ARTICLE | Regulation

Committee advisers weren’t convinced Lykos’ psychotherapy combination is either effective or safe for PTSD

By Selina Koch, Executive Editor

June 5, 2024 1:59 AM UTC

Although there were too many confounding factors to convince FDA’s advisers that Lykos’ MDMA-psychotherapy combination is either effective or safe for PTSD, the outcome is unlikely to read through to other psychedelic therapies in the pipeline.

FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted 2-9 against the assertion that the available data demonstrate the drug-therapy treatment package is effective in patients with post-traumatic stress disorder. The panel voted 1-10 against FDA’s proposed REMS being adequate to achieve a favorable benefit-risk profile…