New study brings MDMA as treatment for PTSD closer to FDA approval

MDMA, commonly referred to as “ecstasy” or “molly,” is on its way to becoming the first psychedelic to receive approval from the Food and Drug Administration (FDA) after a study conducted by an industry-leading research group found that the drug was effective in treating moderate and severe post-traumatic stress disorder (PTSD) among a racially diverse set of patients.  

After successfully carrying out an 18-week Phase 3 clinical trial, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced this week that almost 90 percent of participants who were treated with MDMA-AT — methylenedioxymethamphetamine-assisted therapy — “achieved a clinically meaningful benefit” while almost half met remission criteria by the end of the study. These results were compared with those recorded among a placebo group of 42 patients, only 9 of whom met remission criteria at the trial’s conclusion.

More than a third of patients in the trial identified as nonwhite while almost 27 percent identified their ethnicity as Hispanic/Latino. Although people of color are often excluded from clinical studies, these groups face a higher risk of developing PTSD. A 2019 study found that African Americans have the highest lifetime prevalence of PTSD compared to other racial groups at 8.7 percent. 

Payton Nyquvest, the co-founder and CEO of Numinus Wellness Inc., a mental health care company championing progressive, research-backed and safe psychedelic-assisted therapies celebrated the enormous promise offered by this latest study in a press release.

“Millions of people living with PTSD are hoping to access MDMA-assisted therapy as a safe, effective healing modality,” Nyquvest said. “These positive Phase 3 results represent a genuine and promising leap toward formally acknowledging this treatment and providing universal access.”

Current recommended and FDA-approved treatments for PTSD include the SSRIs — selective serotonin reuptake inhibitors — paroxetine and sertraline. Yet, the efficacy of such medications has been called into question with only 60 percent of patients with PTSD experiencing a response from the antidepressants and only 20 percent to 30 percent reaching complete remission. 

“We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year,” Rick Doblin, founder of MAPS, said in a statement. As MAPS prepares to submit a new formal drug application to the FDA, Doblin hopes that this will be the “first of many psychedelic-assisted therapies to be validated through diligent research.”

Calls like Doblin’s to advance alternative mental health treatments have coincided with a growing effort to decriminalize psychedelic drug use.

Last week, the California state Assembly voted to pass legislation that would make several naturally occurring psychedelic substances — including psilocybin and psilocin, the psychoactive ingredients in hallucinogenic mushrooms, dimethyltryptamine (DMT) and mescaline (excluding peyote) — legal within the state. If eventually approved by California Gov. Gavin Newsom (D), California would become the third state, joining Oregon and Colorado, to decriminalize psychedelics.