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 that this drug is effective based on the data I saw," said Dr. Rajesh Narendran, a University of Pittsburgh psychiatrist who chaired the panel.

Melissa Barone, another panelist and psychologist with the VA Maryland Health Care System agreed. "It seems like there are so many problems with the data," she said per NPR. "Each one alone might be okay, but when you pile them up on top of each other…"

There are only two FDA-approved treatments for PTSD and MDMA would be the first to come on the market in decades. Tuesday’s decision comes at a time when there is growing interest in the use of psychedelic drugs to treat various mental health conditions, including depression and anxiety.

MDMA Advocates Respond

The treatment, in capsule form of MDMA made by public-benefit corporation Lykos Therapeutics, is meant to be administered in combination with talk therapy sessions by a licensed mental health provider.

Representatives of Lykos emphasized the positive findings in clinical data collected in two nearly identical randomized controlled trials. In one, over 190 patients, who received doses of MDMA in addition to therapy, showed a significant reduction in PTSD symptoms compared to placebo.

"In totality, these results support [that] MDMA in combination with psychological intervention provides significant and meaningful reductions in PTSD symptoms and functional impairment in patients with PTSD," said Berra Yazar-Klosinski, chief scientific officer for Lykos.

The decision by the FDA’s panel is a setback for proponents of psychedelic medicine, but it does not necessarily mean the end of research into MDMA-assisted therapy for PTSD. Further studies with more robust data could lead to the FDA reconsidering its position in the future.

PTSD-Related Suicide Leading Cause Of Death Among Veterans

An average of 17 veterans committed suicide per day in 2020 according to the Dept. of Veterans Affairs. Suicide is the second leading cause of death among veterans. The percentage of veterans from conflicts in the Middle East who have experienced PTSD is nearly triple the number of those from the Vietnam War.

Photo courtesy of FDA.