SIGNIFICANT DIFFERENCE IN PTSD SYMPTOMS AFTER MDMA-ASSISTED PSYCHOTHERAPY

An independent data monitoring commission has reviewed the data from the ongoing clinical Phase 3 trial of MAPS.

By Balthazar Malevolent

SIGNIFICANT DIFFERENCE IN PTSD SYMPTOMS AFTER MDMA-ASSISTED PSYCHOTHERAPY

The findings support the best possible interim analysis can provide. MAPS and the joint Psychedelic Science Funders Collaborative have founded the Capstone Fund to collect the $30 million required to complete the research and make MDMA a medicine.

MAPS

Multidisciplinary Association for Psychedelic Studies (MAPS) released the findings of an interim review of the data from the first of its numerous Phase 3 clinical trials of posttraumatic stress disorder (PTSD) - psychotherapy supported by MDMA. It is the best-case scenario for an interim review and it indicates that the U.S. Food and Drug Authority's (FDA) approval of the research program of MAPS is on track.

An independent Data Monitoring Committee performed the study which checked the results of the first 60 out of 100 participants. The analysis revealed a 90 percent or higher probability that the trial would produce statistically significant results when all participants are administered, and that the trial will not require additional participants beyond the first 100. The FDA approved the interim analysis as part of MAPS' FDA Statistical Analysis Plan.

The findings strongly indicate that the FDA has made the right decision to grant MAPS both (1) Breakthrough Therapy Designation for MDMA-assisted PTSD psychotherapy, which accelerates the clinical trial phase and acknowledges MDMA-assisted psychotherapy as a potentially important improvement over PTSD therapies currently available, and (2) Expanded Access, which will give certain patients early access to MDMA-assisted psychotherapy for PTSD prior to approval.

Almost all the interim analyzes do succeed. For example, the only other medication granted Breakthrough Therapy Designation by the FDA for PTSD, Tonix Pharmaceuticals' Tonmya®, failed its interim review in February 2020.

"This is what you dream about within the pharmaceutical drug development community," says Rick Doblin, Ph.D., Founder and Executive Director of MAPS. "The findings of the interim review of MAPS' crucial first Phase 3 trial are the most compelling proof yet that psychotherapy supported by MDMA could help change the lives of people with PTSD. We also trained about 70 new therapists to work on Phase 3, and these findings also show that the procedure is universal, potentially to tens of thousands of therapists around the world.

MAPS, in partnership with the Psychedelic Science Funders Collaborative (PSFC), has initiated a $30 million Capstone Fund to complete this work and make MDMA a legal medication. The Capstone Fund has now raised the first $12 million, putting together a number of supporters who are dedicated to global treatment of PTSD.

"Psychedelic drugs have an incredible potential to treat a variety of mental health problems, but psychedelic work has been underfunded for decades," says Joe Green, co-founder and PSFC President. "This first look at the evidence from a first-ever Phase 3 psychedelic-assisted therapy trial only makes us more optimistic that we are at the cusp of a breakthrough. MDMA-assisted psychotherapy approval will be a catalytic occurrence that would bring prescription medicine into the mainstream. That's why we're excited to work with MAPS in developing the Capstone Fund to get this project to the finish line.

MAPS launches its Phase 3 clinical trials on MDMA-assisted PTSD psychotherapy at 15 sites in the United States, Canada and Israel. Phase 3 trials are scheduled to be completed by 2021, which means the FDA may approve the treatment by 2022. MAPS is currently in the process of securing regulatory approvals in the UЫ, Germany, the Czech Republic and the Netherlands for Phase 2 trials.

Regardless of the worldwide devastation of the COVID-19 pandemic, PTSD affects millions – and maybe millions more, including victims of the disease and their families, professionals in the health care and emergency services, as well as front-line workers who risk their lives to provide essential services.

Being a non-profit agency focusing on mental health care, MAPS is committed to safeguarding the wellbeing of its research staff and participants in clinical trials. MAPS is introducing procedures to minimize the risk of COVID-19 virus exposure and to adhere to physical distance. As a result of this initiative, new enrolment of participants in MAPS-sponsored trials is temporarily postponed, with treatments continuing on a case-by-case basis for some participants as assessed.

"I assume this medication-assisted therapy would be a breakthrough in the therapy of trauma," says Amy Emerson, MAPS Public Benefit Corporation (MAPS PBC) executive director. "I want to thank the researchers who led the experiments, the study volunteers for their time and involvement, the independent Data Review Committee for their careful review and the incredible research team who helped us achieve this milestone in pharmaceutical non-profit growth."

MDMA-Psychotherapy for PTSD

MDMA-assisted psychotherapy allows use of MDMA to improve the effectiveness of PTSD psychotherapy. The treatment includes as part of a psychotherapy course up to three MDMA administrations in combination with psychotherapy in a managed clinical environment. When licensed, patients will not be allowed to take home the MDMA — patients at their local pharmacy will not be filling out their prescriptions. Instead, MDMA-assisted psychotherapy care should only be available through a specialist and only from licensed practitioners in supervised rehabilitation settings.

About MAPS

MAPS was founded in 1986 and is a non-profit research and educational organization that establishes medical, legal and cultural perspectives for individuals to benefit from the careful use of psychedelics and marijuana. MAPS has raised over $80 million since its founding for study and awareness on psychedelic therapy and medical marijuana.

MAPS-sponsored clinical trials are performed by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS founded in 2014 for the sole aim of combining social benefits for MDMA, other psychedelics, and marijuana legal sales revenues.

About PSFC

Psychedelic Science Funders Collaborative (PSFC) is a group of philanthropists committed to promoting psychedelic medicine. A non-profit, PSFC supports study and clinical trials of psychedelic drugs administered by a physician, and patient access to these medications. PSFC was established in 2017 as a result of the observation that psychedelic medicine has the potential to have a significant impact and has a viable path to regulatory approval, but has been underfunded in a systemic way.

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