A company hoping to treat post-traumatic stress disorder by combining MDMA with talk therapy has hit a major roadblock from the US Food and Drug Administration.
Lykos Therapeutics, which is seeking FDA approval, announced on Friday that it had received a rejection letter from the FDA requesting further study of the safety and effectiveness of the potential treatment. Lykos responded by asking the FDA to reconsider its decision, adding that it would request a meeting to “further discuss the FDA’s recommendation regarding the resubmission.”MDMA, also known as Molly or 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 advisors in June to reject MDMA-assisted therapy. The panel questioned the treatment’s long-term effectiveness and safety, the quality of Lycos’ data, and the behavior of therapists who participated in previous Lycos studies. The FDA had the option to act against the panel’s feedback, but the agency reportedly reached a similar conclusion.
A third Phase 3 clinical trial would be years too late for Lycos, according to CEO Amy Emerson, who called the FDA’s letter “deeply disappointing” and argued in a statement that the agency’s requests “can be addressed through existing data, post-approval requirements, or references to the scientific literature.”
Lycos did not make the rejection notice public, and the FDA did not immediately respond to Gizmodo’s request for more information, but an FDA spokesperson told NPR on Friday that “significant limitations in the data included in the application prevent the FDA from concluding that the drug is safe and effective for its proposed indication.”
The spokesperson added that the agency “will continue to encourage research and drug development that will lead to further innovation in psychedelic treatments and other therapies.”
