FDA Rejects MDMA as PTSD Treatment, Calling for More Research
Psychedelic Therapy Denied Approval
In a significant setback for the burgeoning field of psychedelic therapy, the Food and Drug Administration (FDA) has declined to approve MDMA as a treatment for post-traumatic stress disorder (PTSD), despite promising clinical trials and strong support from veterans and mental health experts.
Additional Studies Required
The FDA's decision, announced Friday, stems from concerns about the lack of long-term safety and efficacy data. The agency has requested additional studies to assess the drug's risks and benefits before making a final decision on approval.
Lykos Therapeutics, the drugmaker behind MDMA therapy, expressed disappointment but pledged to continue working with the FDA to provide the necessary data.
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