Psychedelic Therapy

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FDA rejection letter for MDMA Assisted Therapy (mastodon.social)

submitted 1 year ago by PlanetMedicines@lemmy.world to c/psychedelic_therapy@lemmy.world

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"The MAPS-based regimen may not be generalizable to all types of psychotherapy practices. We recommend using an evidence-based standard of care psychotherapy in lieu of the MAPS-developed psychotherapy in any future studies." ie -- cognitive behavioral therapy

Sounds kinda bad for ANY pharmaceutical company who is attempting to patent their own form of psychotherapy rather than using what the FDA considers a standard of care. In their own handouts at the committee meeting for MDMA-Assisted Therapy, on page 65, the FDA writes "The current standard of care for PTSD involves certain modalities of psychotherapy (cognititve behavioral therapy CBT or eye movement desensitization and reprocessing, EMDR) either alone or in combination with pharmacotherapy." The issue wasn't pairing it with therapy. The issue was pairing it with a patented form of therapy that the FDA considers is not "generalizable to all psychotherapy practices".

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