FDA Rejects MDMA Therapy for PTSD: A Blow Against Psychedelic Research

The Food and Drug Administration (FDA) has dealt a blow to the emerging field of psychedelic therapy by rejecting an application from Lykos Therapeutics for approval to administer MDMA as part of therapy for people suffering with post-traumatic stress disorder (PTSD). The ruling is a major setback for the psychedelic medicine revolution, which has been making in-roads after decades on the fringes of regulation and public perception.

The FDA’s ruling last Friday came at a critical time for psychedelic research, which has recently gained support from the Department of Veterans Affairs and bipartisan lawmakers. The rejection of MDMA as an effective treatment for PTSD highlights the ongoing challenges and complexities of bringing psychedelics into mainstream medical practices. 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.”

Supporters of MDMA-assisted therapy argue that the drug can help patients open up emotionally and form deeper connections with therapists during sessions. However, Lykos Therapeutics has not yet convinced the FDA with their evidence. One issue may be that the study was functionally unblinded, as some participants could tell whether they received MDMA or a placebo based on how the drug affected them. Additionally, some scientists have expressed concerns about the drug’s cardiac safety.

Allegations of ethics violations involving sexual misconduct and data suppression further complicated the FDA’s review of Lykos’ clinical trials. Along with these ethical issues, the methodological and operational criticisms also contributed to the FDA’s decision to recommend against Ibogaine-assisted therapy for opioid dependence  and MDMA-for-PTSD therapy under an Investigational New Drug (IND) application.

The stakes of the FDA’s ruling go well beyond MDMA therapy and point to a larger conversation regarding where psychedelics fit with modern medicine going forward. Though some analysts think the FDA’s review pointed out issues specific to MDMA-assisted therapy, others see it as a moment that could set an important precedent for how these types of treatments are regulated in the future.

The FDA’s stance on MDMA for PTSD highlights the complex challenges researchers and developers face in trying to unlock the therapeutic potential of these substances. While mainstream acceptance may be difficult to achieve, these setbacks won’t stop those committed to advancing psychedelic therapies from making progress. “Although disappointing, this move by the FDA highlights the importance of conducting rigorous research into the safety and efficacy of MDMA-assisted therapy,” says Alan Davis, director of the Center for Psychedelic Drug Research and Education at the Ohio State University. “Despite this setback, I am hopeful that there will be a better outcome down the road after more research is completed in the coming years.”

Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision.