Jun 3, 2024 - Technology

FDA report casts doubt on MDMA treatments

Illustration of a pill casting a shadow in the shape of a question mark

Illustration: Sarah Grillo/Axios

A new Food and Drug Administration report questions the safety of using MDMA — also known as ecstasy — to treat PTSD, citing the potential for abuse and possible side effects.

Why it matters: The findings cast new doubts on what could become the first psychedelic-based treatment approved in the U.S. ahead of a related meeting tomorrow.

Friction point: Clinical trials using MDMA to treat PTSD made it difficult to assess safety and effectiveness, FDA staff wrote.

  • They said the studies lacked sufficient data on how the drug induces euphoria or elated mood to make recommendations for monitoring potential abuse by patients.
  • Small sample sizes also made it difficult to confirm that the treatment would not cause liver damage observed in earlier studies of illicit use of the drug, the report states.
  • It's also unclear how much of the benefits came from the drug or the psychotherapy that was paired with it.

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