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.