The potential for psychedelic drugs to serve legitimate medical purposes has become a growing topic of discussion. On August 9, the Food and Drug Administration rejected midomafetamine (MDMA), better known as ecstasy, as a treatment for post-traumatic stress disorder. Had it been approved, it would have marked the first psychedelic to receive FDA approval.
Drug manufacturer Lykos Therapeutics conducted multiple trials to evaluate the safety and efficacy of MDMA in combination with talk therapy to treat PTSD. In declining the company’s application, the FDA cited poorly designed studies and the potential for serious health risks… concerns that were also brought up by the agency’s advisory committee in June.
Experts see the rejection as a minor and temporary setback. “The advisory committee and FDA gave very clear indications of what they’re looking for in terms of study design and adverse event reporting, so Lykos and other companies should know pretty clearly how to proceed going forward if they want to get psychedelics approved,” said Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania.
MDMA was classified in 1985 as a Schedule I drug, meaning it has “no currently accepted medical use and a high potential for abuse.” Nevertheless, the idea of using the drug to treat PTSD has found favor with physicians, veterans, and lawmakers … a groundswell of support that could presage the use of other psychedelics to address mental health disorders in the near future.