In a public meeting, panel members cited inadequate consideration of abuse risks and lack of evidence for MDMA's efficacy with psychotherapy, potentially barring FDA approval of the drug.
The rejection dealt a blow to Lykos Therapeutics, a for-profit public benefit corporation of Maps which sponsored the trials, and reflects a broader setback for the psychedelic movement.
The rejection highlights a perceived conceptual error in the movement's approach, leaning towards symptom elimination rather than psychedelic exploration fostering brain plasticity and addressing psychological suffering.
#mdma-assisted-therapy #psychedelic-movement #fda-approval #brain-plasticity #psychedelic-exploration
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