A panel of experts advising the U.S. Food and Drug Administration (FDA) voted against adopting MDMA as a treatment for post-traumatic stress disorder (PTSD) on Tuesday.
Members of the FDA’s Psychopharmacologic Drugs Advisory Committee said that they did not feel there is sufficient evidence to show that the drug is effective in a 9-2 vote. In a 10-1 vote, experts overwhelmingly said that the benefits of MDMA, commonly known as ecstasy or molly, do not outweigh the risks.
The panel was tasked with evaluating a proposed treatment developed by Lykos Therapeutics, which involves taking prescribed doses of MDMA under the supervision of clinicians providing psychotherapy to treat patients with moderate to severe PTSD. The FDA does not have to abide by the panel’s guidance, but does take its input into consideration. The FDA will announce whether the drug is approved for use in PTSD treatment by Aug. 11.
“We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Lykos Therapeutics CEO Amy Emerson in a Tuesday press release. “We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved.”
Individuals can develop PTSD after a shocking or dangerous event. Symptoms include experiencing flashbacks—which can cause sweating, or an increased heart rate—or having recurring memories or dreams about the traumatic event. People with PTSD might also opt to stay away from places, events, or objects that remind them of the experience, can have trouble relaxing, have difficulty falling asleep, feel irritable, have trouble remembering what happened during the event, socially isolate, and more.
About 6% of the U.S. population will have PTSD at some point in their lives, according to estimates by the National Center for PTSD, though there is no exact number on how many people have PTSD. The Center says people are more likely to be at risk of PTSD if they’ve experienced war, natural disasters, or a pandemic. Veterans are also more likely to experience PTSD, according to the U.S. Department of Veterans Affairs, with female veterans at greater risk than male veterans.
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The FDA has approved two antidepressants for the treatment of PTSD. When evaluating the efficacy of MDMA, the Psychopharmacologic Drugs Advisory Committee reviewed results from two randomized studies that were published in the journal Nature Medicine. Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs who is a temporary voting member on the committee, said there were problems with 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 said at the committee’s meeting, according to the Associated Press. Other members brought up potential concerns about misconduct and bias that could have affected the studies’ results, the Associated Press reports, and they discussed whether patients’ improvement actually came from taking MDMA, or from undergoing intense therapy.
MDMA is a stimulant and hallucinogen, according to the National Institute on Drug Abuse at the National Institutes of Health (NIH). The drug has been shown to trigger feelings of euphoria and closeness, and can distort time and perception. Overdosing on MDMA can lead to liver, kidney, or cardiovascular system failure, brain swelling, or even death. MDMA is currently classified as a Schedule I drug, meaning it is considered to have no medical purpose and has potential for abuse.
FDA briefing documents about the drug being used as a treatment for PTSD said patients could be at “risk for serious harm resulting from patient impairment” if they took MDMA. The FDA also expressed concern about potentially worsening other psychological disorders due to the effects of the drug, which could lead to death, or suicidal behaviors or ideation.
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This isn’t the first time MDMA has been studied for clinical benefits. In the late 1970s to early ‘80s, some psychiatrists began to believe that MDMA helped patients communicate and “achieve insights about their problems,” per the NIH. In the early 1990s, the FDA approved the first human trial that looked at whether MDMA could relieve pain for those who were facing terminal illness, or help as a treatment with psychotherapy. The results of this study have not been published.
In February, the FDA approved the drug’s application for priority review, which is usually designated for drugs that “if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” If the drug is approved, the U.S. would become the second country to do so, after Australian regulators approved medicine containing MDMA and psilocybin for treatment of PTSD and depression earlier this year.