FDA Declines Approval of MDMA-Assisted Therapy for PTSD

Key Points

• The Food and Drug Administration (FDA) has declined to approve the use of MDMA-assisted therapy for treating post-traumatic stress disorder (PTSD).
• The decision was based on safety concerns raised during clinical trials.
• MDMA, commonly known as ecstasy, has shown promise as a potential treatment for PTSD, but more research is needed to address safety issues.

Background

MDMA, a synthetic psychoactive drug, has been investigated as a potential treatment for PTSD in recent years. Studies have shown that MDMA can enhance psychotherapy and reduce symptoms of PTSD in some individuals.

In 2019, the FDA granted breakthrough therapy designation to MDMA-assisted therapy for PTSD, recognizing its potential benefits. However, the FDA required additional safety data before approving the treatment.

FDA's Decision

After reviewing the data from a Phase 3 clinical trial, the FDA determined that the potential risks of MDMA-assisted therapy outweighed the benefits. The trial raised concerns about the drug's potential to cause psychological and cardiovascular adverse events.

In a statement, the FDA said that it "requires substantial evidence of safety and effectiveness before approving any new drug therapy, including MDMA for the treatment of PTSD." The agency added that it "looks forward to reviewing the results of additional clinical trials to further evaluate the potential benefits and risks of MDMA-assisted therapy."

Next Steps

The FDA's decision is a setback for proponents of MDMA-assisted therapy for PTSD. However, researchers and organizations dedicated to developing new PTSD treatments will continue their work.

MAPS (Multidisciplinary Association for Psychedelic Studies), the organization that sponsored the Phase 3 trial, has stated that it plans to conduct further research to address the safety concerns raised by the FDA.