The results from the world’s first Phase 3 clinical study on a psychedelic are in — and they’re significant.
The Multidisciplinary Association for Psychedelic Studies released the results from its Phase 3 trial on MDMA for the treatment of post-traumatic stress disorder.
MDMA, also known by street names ecstasy or molly, is shown to have a very high therapeutic value in treating PTSD when administered in the context of psychotherapy.
The trial treated 90 patients with severe, chronic PTSD, who have been suffering from the condition for an average of 14 years.
After three MDMA-assisted therapy sessions, 67% of patients no longer qualified for a PTSD diagnosis. Additionally, 88% showed a clinically meaningful reduction in symptoms.
A Milestone For The Entire Psychedelics Industry
The success of the MDMA research program could become the first significant milestone for the ongoing “psychedelics renaissance,” as no other psychedelic compound today is as advanced in the clinical research pipeline.
Psilocybin, the active ingredient in magic mushrooms, is undergoing Phase 2 trials and is not expected to become approved before 2025.
MDMA, on the other hand, could be offered to patients legally across the country by 2023, or even 2022, as a MAPS spokesperson told Benzinga in a recent interview.
MAPS is a leading nonprofit in the psychedelics space that was founded 35 years ago with the goal of opening access to psychedelics as therapeutic agents. The organization’s landmark work is the advancement of MDMA through the clinical research pipeline.
Through MAPS’ tireless work, MDMA — a psychedelic empathogen discovered in 1912 and made illegal in 1985 — is inches away from obtaining FDA approval to be used in the treatment of PTSD.
Achieving FDA approval for a Schedule 1 substance would represent a clear and consistent proof of the potential and strength of the psychedelics industry in becoming a profitable and long-term business.
As an incentive for pushing the compound through clinical trials, the FDA will grant MAPS and the MAPS Public Benefit Corporation a limited period of market exclusivity, since MDMA became public domain decades ago.
“We would have a five-to-seven-year exclusivity from the FDA. So we would be the only ones legally able to market and sell MDMA," Brad Burge, former MAPS director of communications, told Benzinga.
The organization plans to use proceeds from the MDMA rollout to fund further research on other psychedelic compounds.
"After that period is up, any other company will be able to make it and sell it. But of course, it'll still be the generic."
The Phase 3 MDMA Study — And Beyond
MAPS Executive Director Rick Doblin said that “as a result of this study and through the persistent and consistent application of scientific rigor, we have demonstrated that MDMA-assisted therapy is likely to provide relief for people diagnosed with PTSD.”
The randomized, blinded, Phase 3 trial enrolled 90 patients with severe, chronic PTSD, who were divided into two groups. The first group of 46 participants received three sessions of MDMA-assisted talk therapy, while the control group of 44 people received a placebo as well as the same talk therapy.
Results were measured after 18 weeks. Sixty-seven percent of participants in the MDMA-assisted therapy group no longer qualified for a PTSD diagnosis after the MDMA-assisted therapy sessions versus 32% in the placebo group.
Eighty-eight percent of participants from the MDMA group experienced a clinically significant reduction in symptoms verus 60% in the control group.
The final version of the study is expected to be published in Nature Medicine, a peer-reviewed journal, later this month.
“The experience of having been traumatized profoundly alters perceptions; self-experience; and capacity to plan, imagine and anticipate. For 88% of people who receive this treatment, we can expect to see a treatment response. This can lead to fundamental shifts in our subjects' perspective on self-capacity, affect regulation, and attitude towards those around them, says Bessel van der Kolk, M.D., a leading PTSD researcher who served as principal investigator for the study’s Boston site.
“These results open the door to a potentially powerful new pathway to healing — once MDMA-assisted therapy has been approved as a treatment for PTSD.”
The organization is now enrolling participants for a second Phase 3 trial, with study sites in the U.S., Canada and Israel.
Additionally, the FDA has given MAPS permission for an expanded access program under which 50 patients can receive MDMA treatment before final FDA approval.
The federal agency has been consistently supportive of MAPS’ MDMA research across the Obama and Trump administrations, and MAPS said it expects the same positive feedback from the Biden administration.
The agency granted MDMA a Breakthrough Therapy designation and allowed MAPS to end the Phase 3 trial early in light of positive results gathered from the Phase 2 trials.
Photo by Alex Green from Pexels.
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