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FDA Faces Critical Decision on MDMA Therapy for PTSD

Upcoming advisory committee meeting will evaluate the safety and efficacy of ecstasy as a treatment for post-traumatic stress disorder.

  • FDA staff express concerns over potential bias and safety risks in clinical trials.
  • MDMA-assisted therapy shows promise but faces scrutiny over trial design and participant blinding.
  • Veterans' groups and some psychiatrists advocate for the approval due to the lack of effective PTSD treatments.
  • Allegations of data suppression and trial misconduct complicate the evaluation process.
  • The FDA may impose strict regulations if the drug is approved, including controlled administration and patient monitoring.
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