FDA Says There is Not Enough Data to Approve MDMA-Assisted Therapy for PTSD

The Food and Drug Administration (FDA) has declined to approve MDMA-assisted therapy for treating post-traumatic stress disorder (PTSD), The New York Times reports.

If approved, MDMA, also known as ecstasy or molly, would have become the first psychedelic compound to be regulated by federal health authorities, the article notes. The FDA asked the company seeking approval for the treatment, Lykos Therapeutics, to conduct an additional clinical trial to determine whether MDMA would be safe and effective.

The FDA’s decision comes after a group of independent experts convened in June by the agency to evaluate the company’s data did not recommend the treatment. The experts voted overwhelmingly that the company had not proven the treatment was effective, and its benefits did not outweigh the risks.

Supporters of psychedelic medicine said they were surprised by the decision because the company’s clinical trials had been designed in consultation with FDA scientists. They said they had assumed the treatment’s promising data would overcome problems in the company’s clinical trials. Lykos said it would appeal the FDA’s decision.