A potential treatment for post-traumatic stress disorder using the hallucinogen MDMA was overwhelmingly rejected by a federal regulatory panel on Tuesday, in what could be a major setback for the use of psychedelics in treating mental illness.
A US Food and Drug Administration (FDA) committee voted 10 against approving MDMA as safe for treating PTSD and 9 against its effectiveness, citing flawed studies, unclear data, and the possibility of harmful side effects.
The FDA does not have to follow the committee’s recommendation on whether to approve MDMA for use, but any sweeping criticism could be used as grounds to deny treatment.
“There seem to be so many problems with the data, and individually they may be fine, but when you add them up it raises a lot of questions about how effective the treatments are,” said panel member Dr. Melissa Decker Barone, a psychologist at the Department of Veterans Affairs.
Tuesday’s committee meeting was the first to consider medical uses of the Schedule 1 hallucinogen, and treatment with MDMA could be the first new treatment for PTSD in decades.
Lycos Therapeutics, the company developing the treatment, is backed by the Multidisciplinary Association for Psychedelic Research, the nation’s leading psychedelic drug advocacy group. statement The company plans to work with the FDA to obtain approval.
“Given the urgent unmet need for PTSD, we are disappointed with today’s vote. We appreciate the committee faced the difficult and unusual challenge of evaluating a treatment that combines medication (MDMA) with a psychological intervention,” CEO Amy Emerson wrote.
The FDA committee expressed particular concern about the diversity of study subjects and the reproducibility of results. The committee noted that because MDMA is a hallucinogen, patients could easily tell whether they had received a placebo or not, making it impossible to “blind” the study.
The hallucinogenic nature of the drug has made it difficult to track its specific effects, as the drug’s general characteristics are hard to describe. MDMA does not cause hallucinations like other hallucinogens, but rather alters the way a person feels.
MDMA treatment advocacy group Healing Breakthroughs roundly criticised the committee’s vote, saying regulators were “missing the forest for the trees”.
“Since 9/11, 6,000 veterans have committed suicide each year,” said Juliana Mercer, the organization’s director of veterans’ services. statement“It’s heartbreaking that despite billions of taxpayer dollars and countless tried and tested treatments that have proven ineffective at ending the veteran suicide epidemic, this statistic remains unchanged.”
The Lycos study criticized by the committee found that MDMA treatment was about 71 percent effective for PTSD.
“The delay in FDA approval of MDMA-AT dashes the hopes of millions of Americans who suffer from MDMA-AT.
“Until this treatment is approved, more veterans’ lives will be needlessly lost to suicide this year and every year,” Healing Breakthrough warned in a statement.
The FDA is expected to make a final decision on the treatment by August 11.
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