• Posted June 5, 2024

FDA Panel Says No to MDMA as Treatment for PTSD

A U.S. Food and Drug Administration advisory panel on Tuesday voted against recommending the psychedelic MDMA for the treatment of post-traumatic stress disorder (PTSD).

In a 10-1 vote, the panel determined the evidence amassed so far fails to show the controversial drug's benefits outweigh its risks, the Associated Press reported.

During the meeting, panel members pointed to flawed study data and significant drug risks, including the potential for heart problems, injury and abuse.

“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,” Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs, said during the meeting, the AP reported.

The FDA is expected to make a final decision by August, but the panel's vote could bolster the agency's reasoning for rejecting the treatment, the AP reported.

MDMA is the first in a series of psychedelics -- including LSD and psilocybin -- that are expected to come before the FDA for review in the next few years, the AP reported.

But on Tuesday, the FDA advisers pointed to flawed studies that could have skewed the results on MDMA, missing follow-up data on patient outcomes and a lack of diversity among participants. The vast majority of patients were white, with only five Black patients receiving MDMA, the AP reported.

Lykos Therapeutics, the company behind the MDMA treatment, said it would work with regulators to address the panel's concerns.

"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," Lykos CEO Amy Emerson said in a statement released after the meeting. "We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system..."

The panel members did note the difficulty of knowing how much of patients' improvement came from MDMA versus the extensive therapy, which totaled more than 80 hours for many patients, the AP reported. Results were further muddied by a large number of patients who had previously used MDMA or other psychedelics recreationally.

Not only that, but because MDMA causes intense experiences, almost all patients in two key studies of the drug were able to guess whether they had received the MDMA or a dummy pill, the AP reported.

“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.

The meeting concluded with several experts encouraging Lykos and the FDA to continue studying psychedelics for PTSD, the AP reported.

“I think this is a really exciting treatment and I'm encouraged by the results to date, but from a safety and efficacy standpoint I feel it's still premature,” said Dr. Paul Holtzheimer of the VA's National Center for PTSD.

More information

The Drug Enforcement Administration has more on MDMA.

SOURCE: Lykos Therapeutics, news release, June 4, 2024; Associated Press