FDA Panel Rejects MDMA Therapy For PTSD, Citing Concerns Over Research Data In Setback For Advocates
A committee of advisors to the U.S. Food and Drug Administration (FDA) dealt a blow to the burgeoning field of psychedelic medicine by recommending against the approval of MDMA-assisted therapy as a treatment for PTSD.
MDMA, also known as ecstasy, has been studied for over a decade as a potential treatment for mental health conditions. The therapy in question involved administering MDMA capsules to patients undergoing psychotherapy sessions with a licensed professional.
Despite some early promise, the FDA’s panel voted 10-1 against approval, raising concerns about the drug’s safety and effectiveness. Specifically, they questioned whether the benefits outweighed the risks. During the Tuesday meeting, the FDA said there was a “striking lack” of documentation of abuse-related adverse events, which would limit the agency’s ability to explain the effects of MDMA or determine its abuse liability, reported Reuters.
FDA Panelists Weigh In
“I’m not convinced at all …