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FDA panel rejects the use of psychedelic drug MDMA to treat patients with PTSD

The agency is still expected to consider other psychedelics — including LSD and psilocybin mushrooms — as potential drugs that can be used to treat patients with post-traumatic stress disorder.
FDA
Posted at 7:21 AM, Jun 05, 2024

A panel of advisers to the U.S. Food and Drug Administration has voted against the use of MDMA — commonly referred to as ecstasy or molly — to treat patients with post-traumatic stress disorder.

It marked the first time the FDA has considered an illicit psychedelic drug for medical use, but experts say the available evidence doesn't show the drug is effective and that the risks outweigh the benefits. The negative ruling could lead to less investment in studying the use of MDMA to treat PTSD — which has primarily been funded by a small group of wealthy investors.

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The U.S. Drug Enforcement Agency currently classifies MDMA as a Schedule I controlled substance, meaning it has "no currently accepted medical use and a high potential for abuse" and is illegal to manufacture, distribute or possess outside of research settings.

Like other psychedelic drugs, MDMA is known for its psychoactive properties. However, it does not cause visual hallucinations and has instead been cited as triggering feelings of euphoria and intimacy.

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While the negative ruling by the FDA panel marks a major setback for the initiative, the drug could still potentially be approved to treat patients with PTSD. The FDA puts stock in the panel's advice but does not have to follow its recommendations.

The agency is also expected in the coming years to consider other psychedelics — including LSD and psilocybin mushrooms — as potential drugs that can be used to treat patients with post-traumatic stress disorder..