PTSD Treatment: Study Brings MDMA Closer to FDA Approval

A new study is bringing MDMA closer to approval from the Food and Drug Administration (FDA) for treating post-traumatic stress disorder (PTSD).

MDMA, commonly referred to as "ecstasy" or "molly," is set to become the first psychedelic to receive FDA approval after the study found that the drug effectively treats people with moderate and severe PTSD among a racially diverse set of patients.

MDMA-Assisted PTSD Treatment

After the researchers successfully carried out an 18-week Phase 3 clinical trial, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that nearly 90% of participants treated using MDMA-AT achieved a "clinically meaningful benefit."

MDMA-AT, also known as methylenedioxymethamphetamine-assisted therapy, also helped nearly half of the participants meet remission criteria by the end of the study. The research results were then compared with those recorded among a placebo group of 42 patients, only nine of whom met remission criteria at the conclusion of the trial, as per The Hill.

The study included more than a third of the patients in the trial who were non-white, while nearly 27% were either Hispanic or Latino. While people of color are often excluded from clinical studies, these groups are more likely to develop PTSD than others.

A study in 2019 found that African Americans have the highest lifetime prevalence of PTSD compared to other racial groups at 8.7%. The co-founder and CEO of Numinus Wellness Inc., a mental health care company championing progressive, research-backed, and safe psychedelic-assisted therapies, Payton Nyquvest, celebrated the results of the recent study.

During a press release, he said that millions of people who have PTSD are hoping to get access to MDMA-assisted therapy because it is seen as a safe and effective healing modality. Nyquvest noted that the positive Phase 3 clinical trial results represent a genuine and promising leap toward formally acknowledging this type of treatment and providing universal access.

Getting the FDA's Approval

A senior author of the recent study, Berra Yazar-Klosinski, said that if approved, MDMA-assisted therapy would be the first novel treatment for PTSD in more than two decades. He added that PTSD patients can finally feel some hope for their conditions, according to the New York Times.

Scientists say that PTSD affects roughly 5% of the adult population in the United States every year. However, at best, conventional therapies and medications only help roughly 50% of patients, said psychiatrist Dr. Stephen Xenakis, the executive director of the American Psychedelic Practitioners Association.

A lead researcher in the study, Jennifer Mitchell, a professor of neurology at the University of California, San Francisco, cautioned that the treatment is not a panacea. She noted that despite the successful results of the study, not everyone responded to the approach.

Mitchell said that a big, unanswered question amid the situation is how long the benefits of the therapy last after the end of the process, said Medical Xpress.