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, with MDMA being just the first of a number of psychedelics in the drug development pipeline.
The FDA’s decision has disappointed psychedelic therapy advocates, and the stock prices of the psychedelic industry leader stumbled with the announcement. 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.
The Conversation asked drug researcher Benjamin Y. Fong from Arizona State University about what the FDA’s decision entails and what it means for the future of psychedelic medications.
