The FDA’s recent rejection of MDMA isn’t surprising. Too many advocates are trying to frame psychedelics as a miracle drug
Earlier this month, an advisory panel rejected MDMA-assisted therapy for PTSD, possibly dooming US Food and Drug Administration (FDA) approval of the drug commonly called ecstasy. In a public meeting alongside FDA staff, panel members said that the research neither adequately accounted for abuse risks nor proved the drug’s efficacy in combination with psychotherapy.
This decision dealt a major blow to Lykos Therapeutics, the for-profit public benefit corporation of the non-profit Multidisciplinary Association for Psychedelic Studies (Maps), which sponsored the trials. More broadly, the rejection has been described as a drastic setback for the psychedelic movement as a whole. For several years now, it seemed that greater acceptance and new legal spaces for psychedelics were a certainty. Then, scientists appeared at the FDA hearing and everything went dark.
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