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.
