{"id":606325,"date":"2024-06-04T21:59:06","date_gmt":"2024-06-05T01:59:06","guid":{"rendered":"https:\/\/platohealth.ai\/fda-panel-snubs-lykos-mdma-therapy-not-psychedelics-generally\/"},"modified":"2024-06-05T05:58:33","modified_gmt":"2024-06-05T09:58:33","slug":"fda-panel-snubs-lykos-mdma-therapy-not-psychedelics-generally","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-panel-snubs-lykos-mdma-therapy-not-psychedelics-generally\/","title":{"rendered":"FDA panel snubs Lykos\u2019 MDMA therapy, not psychedelics generally","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

ARTICLE | Regulation<\/p>\n

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Committee advisers weren\u2019t convinced Lykos\u2019 psychotherapy combination is either effective or safe for PTSD<\/h2>\n

\n By Selina Koch, Executive Editor<\/span>\n<\/p>\n

June 5, 2024 1:59 AM UTC<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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Although<\/span> there were too many confounding factors to convince FDA\u2019s advisers that Lykos\u2019 MDMA-psychotherapy combination is either effective or safe for PTSD, the outcome is unlikely to read through to other psychedelic therapies in the pipeline. <\/span><\/p>\n

FDA\u2019s 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\u2019s proposed REMS being adequate to achieve a favorable benefit-risk profile…<\/p>\n