FDA panel rejects MDMA-based treatment for PTSD

June 5, 2024

A potential treatment for post-traumatic stress disorder using the psychedelic MDMA was overwhelmingly rejected by a panel of federal regulators on Tuesday, marking what could be a major setback for the use of psychedelics in the treatment of mental illness.

The Food and Drug Administration (FDA) panel voted 10-1 against endorsing the safety of MDMA in treating PTSD, and 9-2 against its efficacy. The group cited flawed studies, unclear data and potential for damaging side effects.

The FDA is not required to follow the panel’s recommendation in whether to approve the use of MDMA, though the thorough criticism could be used as a rationale to reject the treatment.

“It seems like there are so many 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,” said panel member Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.

Tuesday’s panel meeting was the first time it ever considered the use of a Schedule 1 psychedelic drug for medical use. The MDMA treatment could be the first new treatment for PTSD in decades.

Lykos Therapeutics, the company behind the treatment, is backed by the country’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies. It said in a statement that it will work with the FDA to achieve approval in the future.

“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,” CEO Amy Emerson wrote. 

The FDA panel specifically noted concerns about the diversity of the studies’ subjects and the replicability of its results. The panel noted that because MDMA is a psychedelic, patients could easily determine if they were given a placebo dose, making the study “blinding” impossible. 

The drug’s psychedelic nature also made its specific impacts harder to track due to the general difficult-to-describe nature of the drug. MDMA does not cause hallucinations as with other psychedelics but rather changes a person’s emotions. 

MDMA treatment advocacy group Healing Breakthroughs thoroughly criticized the panel’s vote, saying regulators had “missed the forest for the trees.”

“Six thousand veterans have died from suicide every single year since 9/11,” Juliana Mercer, the group’s veteran advocacy director, said in a statement. “This is a gut-wrenching statistic that has remained unchanged, despite billions of taxpayer dollars and myriad treatments that have proven ineffective in bringing the veteran suicide epidemic to an end.”

The Lykos study, which the panel criticized, found that the MDMA treatment had about 71 percent efficacy for PTSD.

“Delaying FDA approval of MDMA-AT dashes the hopes of millions of Americans who suffer

from PTSD,” Healing Breakthrough warned in a statement. “It also means that more veteran lives will be unnecessarily lost to suicide this year, and every year, until this therapy is approved.”

The FDA is expected to issue its final decision on the treatment by Aug. 11.