A company seeking to combine MDMA and talk therapy to treat post-traumatic stress disorder just suffered a major setback from the U.S. Food and Drug Administration.
Lykos Therapeutics, which is aiming for FDA approval, said Friday it received a rejection letter from the FDA requesting more research into the safety and effectiveness of the potential treatment. Lykos responded that it hoped the FDA would reconsider the decision, adding that it would request a meeting “to further discuss the agency’s recommendation for resubmission.” MDMA, also known as molly and ecstasy, is a lab-made drug developed more than a century ago by chemists at German pharmaceutical giant Merck.
The decision follows an earlier vote by FDA advisers, who rejected MDMA as an adjunctive therapy in June. The group raised questions about the long-term efficacy and safety of the treatment, the quality of the Lykos data and the conduct of therapists involved in early Lykos studies. While the FDA has the option to act on its panel’s feedback, the agency reportedly came to a similar conclusion.
Lykos CEO Amy Emerson said conducting a third Phase 3 trial would set the company back years. Emerson called the FDA’s letter “very disappointing” in a statement and said the agency’s request “could be addressed through existing data, post-approval requirements or by reference to the scientific literature.”
Lykos did not release the rejection letter, and the FDA did not immediately respond to Gizmodo’s request for more information. However, an agency spokesperson told NPR on Friday that “the data contained in the application have significant limitations that prevent the agency from concluding that the drug is safe and effective for the proposed indication.”
The spokesperson added that the agency “will continue to encourage research and drug development to further innovate psychedelic and other therapies.”
