The US Food and Drug Administration (FDA) has turned down the application to approve MDMA, or ecstasy, as a treatment for post-traumatic stress disorder (PTSD), according to a statement from drug sponsor Lykos Therapeutics. The agency has requested an additional Phase 3 trial to further assess the safety and efficacy of the therapy.
The FDA has denied Lykos Therapeutics’ application to approve MDMA, also known as ecstasy, for treating PTSD, despite promising results from late-stage clinical trials. These trials, involving around 200 participants, combined MDMA with talk therapy, featuring three eight-hour MDMA sessions spaced a month apart, alongside additional therapy.
MDMA, an entactogen known for fostering emotional openness, is currently classified as a Schedule I drug, indicating no accepted medical use and high abuse potential. This represents the FDA’s first evaluation of a psychedelic drug for medical use, a decision that could significantly impact the field.
In June, an independent FDA advisory committee voted against the treatment, citing concerns about trial integrity and missing safety information. While acknowledging the potential benefits of the treatment, the committee questioned how much the accompanying talk therapy influenced the results, highlighting the need for further research and clarification.
The FDA has rejected Lykos Therapeutics’ application for MDMA as a treatment for PTSD, despite initial positive findings indicating that participants experienced significant and lasting improvements in symptoms. The agency, however, raised concerns about the safety and completeness of the efficacy data from the Phase III trials.
While MDMA has shown promise, the FDA noted potential risks related to heart and liver health, including increased blood pressure and pulse, and incomplete assessments of liver function. The research also failed to adequately address MDMA’s abuse potential within the treatment context.
Lykos Therapeutics plans to address the FDA’s concerns and will seek a meeting with the agency to discuss further steps. The company remains hopeful that additional trials will resolve the issues raised and plans to resubmit its application.
With PTSD affecting approximately 13 million adults in the US annually, current treatments remain limited in scope and effectiveness. Public Citizen, a nonprofit consumer advocacy group, supported the FDA’s decision, emphasizing the need for rigorous evidence of safety and effectiveness before approving new treatments. Dr. Robert Steinbrook of Public Citizen’s Health Research Group commended the FDA for its cautious approach, encouraging better clinical trials for psychedelic therapies.
Veterans organizations have voiced strong disappointment over the FDA’s decision to reject MDMA as a treatment for PTSD. Martin Steele, President of the Veteran Mental Health Leadership Coalition, and Brett Waters, Executive Director of Reason for Hope, criticized the decision, arguing that the FDA had tools at its disposal to approve the treatment conditionally, with safety data collection and post-marketing studies.
They lamented that veterans might now be forced to seek MDMA therapy through unregulated channels or abroad, a situation they describe as both tragic and unacceptable. The groups remain hopeful that MDMA-assisted therapy will eventually gain approval but believe that the current decision will result in continued suffering and loss of life among veterans.
