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.