Panel Rejects Psychedelic Drug MDMA as PTSD Treatment
Federal health advisers have rejected the first-ever proposal to use MDMA as a treatment for PTSD.

WASHINGTON — A groundbreaking proposal to use the mind-altering drug MDMA for treating PTSD faced strong criticism on Tuesday. This decision marks a significant setback for psychedelic advocates aiming for federal approval to integrate these banned drugs into mainstream medicine.

A panel of advisers to the Food and Drug Administration (FDA) voted 10-1 against MDMA’s overall benefits in treating PTSD, citing flawed study data, questionable research conduct, and significant drug risks, including potential heart problems, injury, and abuse.

“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 about how effective the treatment is,” said Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.

The FDA is not required to follow the panel’s advice and is expected to make a final decision by August. However, the negative opinion could bolster the agency’s rationale for rejecting the treatment.

MDMA is the first in a series of psychedelics — including LSD and psilocybin — expected to come before the FDA for review in the coming years as interest in these drugs’ medical potential resurges. Advocates believe these substances could revolutionize mental health treatment.

On Tuesday, FDA advisers criticized the research submitted on MDMA, also known as ecstasy or molly. Panelists pointed to flawed studies, missing follow-up data, and a lack of diversity among participants. The vast majority of patients were white, with only five Black patients receiving MDMA, raising questions about the generalizability of the results.

“The fact that this study has so many white participants is problematic because I don’t want something to roll out that only helps this one group,” said Elizabeth Joniak-Grant, the panel’s patient representative.

The advisers also highlighted allegations of misconduct in the trials. Incidents include a 2018 report of apparent sexual misconduct by a therapist and her husband while treating a patient.

Lykos Therapeutics, the company behind the study, stated it had reported the incident to the FDA and regulators in Canada, where the therapist is based. Lykos, essentially a spinoff of the Multidisciplinary Association for Psychedelic Studies (MAPS), said it would address the panel’s concerns.

“While we are disappointed in the vote, we are committed to continuing to collaborate with the FDA during their ongoing review,” the company stated. The FDA is expected to issue its decision by August 11.

The negative panel ruling could further derail financial investments in the fledgling psychedelic industry, which has mainly been funded by a small number of wealthy backers. Many startup companies studying psilocybin, ketamine, and other drugs for conditions like depression and addiction have struggled to raise money.

MDMA does not cause the visual hallucinations commonly associated with psychedelics. Instead, it triggers feelings of intimacy, connection, and euphoria. When used to enhance talk therapy, the drug appears to help patients process their trauma and let go of disturbing thoughts and memories.

The panel questioned the reliability of the results reported by Lykos, given the difficulties of objectively testing psychedelic drugs. Almost all patients in two key studies were able to guess whether they had received MDMA or a placebo, undermining the study’s validity.

“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 panel also noted the difficulty in determining how much of the patients’ improvement was due to MDMA versus the extensive therapy, which totaled more than 80 hours for many patients. Results were further complicated by the large number of patients who had previously used MDMA or other psychedelics recreationally.

Nearly three dozen public speakers addressed the panel, including veterans who said they benefited from MDMA therapy, medical professionals who advised against its use, and journalists and researchers who detailed the allegations of misconduct.

Several experts encouraged Lykos and the FDA to continue studying psychedelics for PTSD, citing the field’s potential to help patients. “I think this is a really exciting treatment and I’m encouraged by the results to date,” said Dr. Paul Holtzheimer of the VA’s National Center for PTSD, “but from a safety and efficacy standpoint, it’s still premature.”