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Abstract: 

Drugmaker Lykos Therapeutics announced on Aug. 9, 2024, that the Food and Drug Administration declined to approve the company’s application for the use of MDMA-assisted therapy in the treatment of post-traumatic stress disorder. It is the first such decision issued on a psychedelic drug application. Many investors and researchers have been predicting a psychedelics boom and the FDA’s decision has disappointed psychedelic therapy advocates. But the FDA did make recommendations as to how the application could be improved in such a way that MDMA might receive future approval. Yet another setback came days later when the journal Psychopharmacology retracted three papers related to MDMA-assisted therapy, citing “protocol violations amounting to unethical conduct,” particularly in one clinical trial. Drug researcher Benjamin Y. Fong from Arizona State University answers questions about what the FDA’s decision entails and what it means for the future of psychedelic medications.

Keywords: Midomafetamine; MDMA-assisted therapy; PTSD

Affiliations:  1: Arizona State University.