FDA Holds Back MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

A company seeking to treat post-traumatic stress disorder with a combination of MDMA and talk therapy just suffered a major setback from the U.S. Food and Drug Administration.

Lykos Therapeutics, the firm aiming for FDA approval, said on Friday that it received a rejection letter from the agency, which called for more research into the potential treatment’s safety and efficacy. Lykos said in response that it wants the FDA to reconsider the decision, adding that it will request a meeting to “further discuss the agency’s recommendations for a resubmission.” MDMA, also known as molly and ecstasy, is a lab-made drug developed more than a century ago by a chemist at the German pharmaceutical giant Merck.

The decision follows an earlier vote from FDA advisors, who rejected the MDMA-assisted therapy in June. The panel questioned the treatment’s long-term efficacy and safety, the quality of Lykos’ data, and the conduct of therapists who participated in earlier Lykos studies. While the FDA had the option to act against its panel’s feedback, the agency reportedly reached a similar conclusion.

According to Lykos CEO Amy Emerson, conducting a third phase 3 trial would set the firm back several years. Calling the FDA’s letter “deeply disappointing,” Emerson argued in a statement that the agency’s requests “can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”

Lykos did not publish the rejection letter, and the FDA did not immediately respond to Gizmodo’s request for more information. However, a spokesperson for the agency told NPR on Friday, “there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.”

The spokesperson added that the agency “will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies.”