A specialist advisory panel to the U.S. Food and Drug Administration (FDA) voted 9-2 against the acceptance of MDMA as a treatment for post-traumatic stress disorder (PTSD) on Tuesday.
During the FDA’s Psychopharmacologic Drugs Advisory Committee session, panel members expressed a lack of sufficient evidence supporting the effectiveness of the drug. In a 10-1 vote, the experts asserted that the potential benefits of MDMA, commonly known as ecstasy or molly, do not outweigh the affiliated risks.
The panel was tasked with assessing a proposed treatment developed by Lykos Therapeutics, which involves patients ingesting prescribed doses of MDMA while under the supervision of clinicians providing psychotherapy. Although not bound by the panel’s guidance, the FDA acknowledges this input in their decision-making process. The FDA’s final decision on the approval of MDMA for PTSD treatment is expected by Aug. 11.
Lykos Therapeutics CEO Amy Emerson expressed disappointment in the vote, recognizing the unmet needs of PTSD sufferers. She affirmed the company’s commitment to address concerns and collaborate with the FDA to introduce MDMA-assisted therapy responsibly into the healthcare system if approved.
PTSD may develop following exposure to a traumatic or dangerous event. Symptoms may include flashbacks accompanied by physical reactions such as sweating or increased heart rate, recurring memories or dreams related to the event, avoidance of reminders, difficulty relaxing, sleep disturbances, irritability, memory impairment, social withdrawal, and more.
Approximately 6% of the U.S. population experiences PTSD, with varying estimates. The National Center for PTSD highlights elevated risk for individuals exposed to war, natural disasters, or pandemics. Veterans are also more likely to develop PTSD, particularly female veterans.
The FDA has previously approved antidepressants for PTSD treatment. In evaluating MDMA’s efficacy, the Psychopharmacologic Drugs Advisory Committee reviewed findings from two randomized studies published in the journal Nature Medicine. Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs and a temporary voting member of the committee, expressed concerns about the data. “Each one alone might be OK, but when you pile them on top of each other… there’s just a lot of questions I would have about how effective the treatment is,” she stated at the committee’s meeting, . Other members raised potential issues of misconduct and bias that could have influenced the study results, and questioned whether improvements seen in patients were attributed to MDMA or the intensive therapy, according to the Associated Press.
MDMA is a stimulant and hallucinogen, as classified by the National Institutes of Health (NIH). The drug can induce feelings of euphoria and closeness and distort time and perception. Overuse of MDMA can result in liver, kidney, or cardiovascular failure, brain swelling, or even death. MDMA is currently classified as a Schedule I drug, indicating its lack of accepted medical use and high potential for abuse.
FDA warnings regarding the use of MDMA for PTSD treatment include potential risks of patient impairment and serious harm. The FDA also expressed concern about the exacerbation of other psychological disorders due to the drug’s effects, potentially leading to suicidal behaviors or ideation.
MDMA has been studied for potential clinical benefits in the past. From the late 1970s to early 1980s, some psychiatrists believed that MDMA facilitated patient communication and “achieve insights about their problems,” . In the early 1990s, the FDA approved the first human trial to examine MDMA’s potential in reducing pain for terminally ill patients or as a therapeutic aid in psychotherapy. The findings from this study have not been published.
In February, the FDA granted priority review status to the drug’s application, which is typically given to treatments that, if approved, would represent significant advancements in safety or efficacy compared to standard therapies. If approved, the U.S. would become the second country to do so, following Australia’s earlier approval this year of a treatment containing MDMA and psilocybin for PTSD and depression.