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Sunday, September 25, 2022

MDMA Could be a Massive Game-Changer in the Treatment of PTSD

Post-traumatic stress disorder (PTSDF) affects millions of people. In fact, according to The Recovery Village, about eight million Americans currently deal with PTSD. In addition, about 20% of people who experience a traumatic event will develop PTSD at some point. Unfortunately, according to American Family Physician, “Nearly 40% and more than 55% who took FDA-approved PTSD medications Paxil or Zoloft, respectively, saw no reduction in their symptoms.” Fortunately, psychedelic companies are finding that MDMA has been useful in treatment of PTSD, which could be a strong catalyst for Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF), Mind Medicine (NASDAQ:MNMD)(NEO:MMED), COMPASS Pathways (NASDAQ:CMPS), Field Trip Health Ltd. (TSX:FTRP)(NASDAQ:FTRP), and Cybin Inc. (NEO:CYBN)(NYSE:CYBN).

According to the New York Post, in the journal “Nature Medicine, authors from New York University, UC San Francisco and led by San Jose, California’s nonprofit MAPS (Multidisciplinary Association for Psychedelic Studies), patients with severe PTSD – including common comorbidities – were given three doses of MDMA, or ‘ecstasy,’ in conjunction with manualized therapy over a period of 18 weeks.”

They found that, “compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities,” they wrote. “We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation,” as also quoted by the New York Post.

Look at Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF), For Example

Numinus Wellness, a leader in psychedelics-focused mental healthcare, recently announced that it has secured two new Canadian psychedelic clinics that will host the Canadian sites of the MAPS Public Benefit Corporation (MAPS PBC) study “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX).”

In addition to managing the two new clinics, which are fully compliant with Health Canada regulations and ready to provide MDMA-assisted therapy as part of the trial, Numinus will host the Montreal and Vancouver sites of MAPPUSX, which will continue to study the safety and efficacy of MDMA in treating severe PTSD, under the leadership of MAPS PBC as study organizer.

“We are honored to host the Canadian sites of the MAPPUSX trial as we continue to examine the important findings around MDMA-assisted therapy for PTSD,” said Dr. Joe Flanders, VP, Psychology, Numinus and therapist for the Montreal site of the trial. “Our clinical and research teams are well positioned to implement MAPS’ research and, ultimately, to work with MAPS on the translation of research findings into mainstream clinical practice. We are excited about this study in both BC and Quebec and look forward to how the MAPPUSX study supports expanded collaboration in the future.”

To date, 25 Numinus-affiliated therapists have gone through MAPS’ training program for delivery of MDMA-assisted therapy and a number of these therapists will have roles in the trial. The trial will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (MAPP1) or who were not able to receive treatment due to COVID-19 restrictions.

“We are happy to work with a trusted ally to quickly complete the extension trial at the Canadian sites” said Rick Doblin, Ph.D. the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). “As we get closer to our goal of making MDMA-assisted therapy a reality, it is critical that we work with clinics who will advance making this treatment widely accessible in real-world settings.”

To accomplish this next step in the MAPPUSX study, Numinus has assumed the leases of two new clinics, the Vancouver and Montreal psychedelic-assisted psychotherapy clinics that were previously used to conduct MAPS PBC’s earlier study; “[a] multi-site phase 3 study of MDMA-assisted psychotherapy for PTSD (MAPP1).” In that trial, 88% of participants experienced a clinically meaningful reduction in symptoms and 67% no longer qualified for a PTSD diagnosis. The highly statistically significant results and excellent safety record suggest MDMA-assisted therapy will be an effective treatment for severe, chronic PTSD.

Payton Nyquvest, CEO, Numinus, added, “We are thrilled that our two new locations, which are purpose-developed for psychedelic-assisted therapy, regulatorily compliant and leading in industry standards, can be used to help advance this crucial work on psychedelic medicine. We look forward to deepening our collaboration with MAPS while expanding the resources and solutions available to those suffering from PTSD.”

Securing the Canadian sites will further allow Numinus to expand its clinical activities in Quebec and BC, including its ketamine-assisted psychotherapy program, which is available in both provinces.

NOTE: The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. Food and Drug Administration (FDA), does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.

Other related developments from around the markets include:

Mind Medicine, a leading biotech company developing psychedelic-inspired therapies, is pleased to announce an expansion of its pipeline with the launch of a program to develop R(-)-MDMA for the treatment of social anxiety and functioning in diagnoses that include Autism Spectrum Disorder (ASD). This program represents a significant expansion and diversification of MindMed’s pipeline and furthers the Company’s mission to bring innovative products to benefit patients and address unmet medical needs. Social anxiety and impairments in social functioning are hallmarks of ASD, which occurs in approximately 2% of individuals in the US. At present, there are no approved therapies for the core symptoms of ASD and there remains a significant unmet need for novel therapies to support people with ASD.

COMPASS Pathways, a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced it will be conducting a phase II clinical trial to assess the safety and tolerability of COMP360 psilocybin therapy in post-traumatic stress disorder (PTSD). The study expands COMPASS’s research pipeline in psilocybin therapy with COMP360, the company’s proprietary formulation of synthetic psilocybin which COMPASS is currently developing for treatment-resistant depression.

Field Trip Health Ltd., a global leader in the development and delivery of psychedelic therapies, announced the opening of their Seattle clinic, their sixth in the United States, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC. As the largest provider of psychedelic-assisted therapies globally, Field Trip continues to distinguish itself as a leader in the emerging psychedelic industry with continued expansion and growing demand.

Cybin Inc., a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM“, announced positive CYB003 pre-clinical findings that demonstrate multiple advantages for its newly developed novel deuterated psilocybin analog over oral psilocybin for the treatment of mental health. “Multiple academic studies have shown that psilocybin may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. Cybin has always strived to develop safer and more effective therapies for patients, which has guided our multiple psilocybin programs: CYB001, CYB002, and CYB003,” said Doug Drysdale, Cybin’s Chief Executive Officer.

Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Numinus Wellness Inc. has paid three thousand five hundred dollars for advertising and marketing services to be distributed by Winning Media. Winning Media is only compensated for its services in the form of cash-based compensation. Winning Media owns ZERO shares Numinus Wellness Inc. Please click here for full disclaimer.

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