The US Food and Drug Administration (FDA) has rejected a proposal to use MDMA, commonly known as ecstasy or molly, for treating post-traumatic stress disorder (PTSD). The FDA was evaluating the use of this psychedelic drug, developed by Lykos Therapeutics, in combination with talk therapy.
Lykos Therapeutics reported that the FDA’s denial was due to concerns about the limited clinical data and doubts about whether psychotherapy is necessary for the treatment’s effectiveness. The agency has requested further research.
The FDA stated that it could not determine the safety and efficacy of the drug for PTSD based on the current data. “The FDA is responsible for ensuring that drugs are both safe and effective,” the agency told the BBC. “To approve a drug, we must have research and data that demonstrate its safety and effectiveness for its intended use.”
Lykos Therapeutics plans to continue working with the FDA but noted that additional research could take years. The company expressed disappointment with the decision. “The request for another study is deeply disappointing for everyone involved in this pioneering effort, and especially for the millions of Americans with PTSD who have not had new treatment options in over two decades,” said Amy Emerson, CEO of Lykos Therapeutics.
This is the first time the FDA has reviewed a psychedelic for medical use. MDMA is currently classified as a Schedule I drug under the Controlled Substances Act, alongside heroin and cannabis. This classification denotes drugs with no accepted medical use and a high potential for abuse.
While MDMA has been promoted for its potential therapeutic benefits, FDA advisers have raised doubts. In June, an expert panel voted 10-1 against the overall benefits of MDMA for treating PTSD. Nine of the 11 advisers believed that the available data did not support the drug’s effectiveness. Although one Lykos trial showed that 71% of participants in the treatment group no longer met PTSD criteria compared to 48% in the placebo group, the FDA panel had concerns. These included questions about the long-term benefits, the study design, and potential risks such as heart problems, injury, and abuse.
The FDA is not required to follow the committee’s recommendations but often does. Last year, Australia’s medicines regulator approved MDMA and other drugs to assist therapy sessions, a move that remains a significant development in the field.
