FDA panel declines approval of MDMA therapy for PTSD
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An FDA advisory panel has recently voted against MDMA-assisted therapy for post-traumatic stress disorder (PTSD), indicating that the clinical trial data did not outweigh the potential risks. Concerns were raised regarding the safety and long-term effectiveness of integrating MDMA, commonly known as ecstasy, into therapeutic settings. This decision poses a significant setback for advocates of psychedelic-aided therapy who believe that MDMA can significantly enhance the therapeutic process for those with severe PTSD. The panel's rejection highlights the need for further research to resolve safety issues before such treatments can be widely approved.
Source
Mitchell, J.M., Ot’alora G., M., van der Kolk, B. et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med 29, 2473–2480 (2023). https://doi.org/10.1038/s41591-023-02565-4
Additional Reading
https://www.nytimes.com/2024/06/04/health/fda-mdma-therapy-ptsd.html