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…
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- Source: https://www.biocentury.com/article/652612/fda-panel-snubs-lykos-mdma-therapy-not-psychedelics-generally