MAPS Inches Closer to Federal New Drug Application for MDMA

One of the psychedelics industry’s leading researchers, the Multidisciplinary Association for Psychedelic Studies, this week announced the successful completion of Phase 3 clinical trials for an MDMA treatment to help patients suffering from post-traumatic stress disorder, and said it brings the group a major step closer to filing a federal request to bring the treatment to market.

The study, which was run by the MAPS Public Benefit Corporation and published in Nature Medicine, found that “45 of 52 (86.5%) participants treated with MDMA-AT achieved a clinically meaningful benefit, and 37 of 52 (71.2%) participants no longer met criteria for PTSD by study end.”

The most recent study involved 104 patients, with only 53 that received MDMA and another 51 that took placebos, and none of the participants had serious adverse events, while most experienced reduced PTSD symptoms.

Researchers observed “improvements were observed across all domains, including family life, social life and work life,” according to the findings.

In other words, the studies appear to have been a smashing success in providing solid evidence that MDMA can alleviate PTSD.

Now, MAPS is preparing to submit a formal new drug application to the U.S. Food and Drug Administration by end of year, meaning it’s nearing the finish line for when it can offer MDMA treatments legally to patients.

“We hope that MDMA-assisted therapy for PTSD will be approved by the FDA next year,” Dr. Rick Doblin, founder of MAPS, said in a statement, adding that he hopes it will be only the “first of many psychedelic-assisted therapies to be validated through diligent research.”

While many psychedelics companies are still wading through the lengthy research and red tape – as well as raising capital – to eventually bring such treatments to market for patients, the MAPS announcement proved an encouragement for its colleagues.

In a press release, Numinus Wellness Inc. (OTCQX: NUMIF) co-founder and CEO Payton Nyquvest said the MAPS news is a “significant milestone” for “humanity as a whole,” and suggested it could provide a much-needed breakthrough.

“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.”

“It goes without saying that the industry tips its hat to Rick Doblin and the entire MAPS team,” Nyquvest continued. “They have been tirelessly advocating for the mental health industry through their work over the past 38 years, guiding us on this crucial journey. The Numinus team is proud to be a longstanding ally and partner of MAPS and will continue supporting the organization’s efforts and advocacy with our extensive resources in the US and Canada.”

In yet another celebratory release, Healing Commercial Real Estate’s CEO, Cody Shandraw, said the news “fills us with an overwhelming sense of excitement and anticipation.”

“Because of the global need for these innovative therapies, we anticipate that the demand from patients for this lifesaving treatment will necessitate 16,000 new clinics in the US to support MDMA therapy by 2031,” Shandraw said, adding that means “work must begin now” on psychedelic treatment infrastructure.

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