On Friday, drugmaker Lykos Therapeutics received word from the Food and Drug Administration that the agency has decided not to approve MDMA-assisted therapy for PTSD at this time. Instead, the agency asked the drugmaker to further study the safety and efficacy of the treatment. The heavily anticipated announcement came in the form of a “complete response letter” from the FDA to Lykos, according to a company press release.
It represents a significant blow for the company and the broader movement to bring psychedelics into the mainstream of mental health care. Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision. Lykos’ CEO Amy Emerson called the FDA’s request for another phase 3 trial “deeply disappointing,” and said conducting the study “would take several years.
” She added that many of the requests from the agency “can be addressed with existing data, post-approval requirements or through reference to the scientific literature." “The FDA's decision to request another phase 3 study is a major setback for the field," said Jennifer Mitchell, a professor at the University of California, San Francisco and an author of the MDMA studies, in Lykos’ press release. The treatment had garnered considerable support from patients, leaders in the field of mental health and psychedelics and politicians from both parties.
In recent weeks, advocates mounted a major public pressure campaign, emphasizing the dire need for new and.