A panel of experts advising the US 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 Psychopharmacological Drug Advisory Committee said they do not feel there is enough evidence to show the drug is effective in a 9-2 vote. In a 10-1 vote, experts overwhelmingly said 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 doctors who provide psychotherapy to treat patients with moderate to severe PTSD. The FDA does not have to follow the panel’s guidance, but takes its input into account. The FDA will announce whether the drug will be approved for use in treating PTSD by August 11.
“We are disappointed with today’s vote given the urgent unmet need in PTSD and recognize that the committee faced a challenging and unusual task, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Amy, CEO of Lykos Therapeutics. Emerson on a Tuesday Press release. “We remain committed to working with the FDA to address outstanding issues so that we can find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved.”
Individuals may develop PTSD after a shocking or dangerous event. Symptoms include try flashbacks – which can cause sweating or increased heart rate – or having recurring memories or dreams about the traumatic event. People with PTSD may also choose to stay away from places, events or objects that remind them of the experience, they may have difficulty relaxing, have difficulty falling asleep, feel irritable, have difficulty remembering what happened during the event, socially isolate themselves and much more.
About 6% of the U.S. population will have PTSD at some point in their lives, according to estimates from the the National Center for PTSD, although there is no exact number of how many people have PTSD. The Center says people are more likely to be at risk for PTSD if they have experienced war, natural disasters or a pandemic. Veterans too 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. In evaluating the effectiveness of MDMA, the Psychopharmacological Medicines Advisory Committee reviewed the results of two randomized trials 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, said there were problems with the data. “Each on its own might be fine, but when you stack them on top of each other… there are a lot of questions I would have about the effectiveness of the treatment,” she said at the committee meeting, according to the Associated Press. Other members raised possible concerns about misconduct and bias that could have affected study results, reports the Associated Press, and discussed whether the patients’ improvement really came from the use of MDMA or 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 demonstrated trigger feelings of euphoria and closeness, and can distort time and perception. MDMA overdose can lead to liver, kidney or cardiovascular system failure, brain swelling or even death. MDMA is currently classified as a Schedule I medication, meaning it is considered to have no medical purpose and potential for abuse.
FDA information documents about the drug being used as a treatment for PTSD said patients could be “at risk of serious harm resulting from patient impairment” if they took MDMA. The FDA also expressed concern about the potential worsening of other psychological disorders due to the drug’s effects, which could lead to death, or suicidal behaviors or ideation.
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This is not the first time MDMA has been studied for clinical benefits. From the late 1970s to the early 1980s, some psychiatrists began to believe that MDMA helped patients communicate and “gain insights into their problems.” according to the NIH. In the early 1990s, the FDA approved the first human trial that looked at whether MDMA could ease pain in those facing terminal illnesses or help as a psychotherapy treatment. The results of this study have not been published.
In February, the FDA approved the drug’s application for priority review, which is normally designated for drugs that “if approved, there would be significant improvements in the safety or effectiveness of treating, diagnosing, or preventing serious diseases when compared with standard applications.” If the drug is approved, the US would become the second country to do so, after Australian regulators approved medicines containing MDMA and psilocybin for treating PTSD and depression earlier this year.
This story originally appeared on Time.com read the full story
