FDA Withholds MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

A company seeking to treat post-traumatic stress disorder with a combination of MDMA and talk therapy recently received a major pushback from the US Food and Drug Administration.

Lykos Therapeutics, the company aiming for FDA approval, said on Friday it had received a denial letter from the agency, demanding more research into the safety and effectiveness of the potential treatment. Lykos responded by saying he wanted the FDA to reconsider the decision, adding that he would request a meeting to “continue to discuss the agency’s recommendations to be resubmitted.” MDMA, also known as molly and ecstasy, is a lab-made drug developed over a century ago by a chemist at the German pharmaceutical company Merck.

The decision follows a previous vote by FDA advisors, who rejected MDMA-assisted treatment in June. The panel questioned the effectiveness and long-term safety of the treatment, the quality of Lykos’ data, and the ethics of the physicians who participated in the earlier Lykos studies. Although the FDA had the option of acting against its panel’s response, the agency reportedly reached the same conclusion.

According to Lykos CEO Amy Emerson, the third-party lawsuit will set the company back several years. Calling the FDA’s letter “very disappointing,” Emerson said in a statement that the agency’s requests “can be handled with existing data, post-approval requirements or by reference to the scientific literature.”

Lykos did not publish the denial 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 in the data contained in the application that prevent the agency from concluding that the drug is safe and effective for the proposed indications.”

The spokesperson added that the organization will “continue to promote research and development of drugs that will advance psychedelic and other therapies.”