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Numinus Wellness Inc
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Numinus cheers MAPS phase 3 MDMA-AT results

2023-09-19 12:02 ET - News Release

Mr. Payton Nyquvest reports


Numinus Wellness Inc. has congratulated the Multidisciplinary Association of Psychedelics Studies (MAPS) on the results of its phase 3 results. These findings were published last week in the peer-reviewed medical journal, Nature Medicine.

As largely expected, the results of the confirmatory phase 3 study, named MDMA (3,4-methylenedioxy-N-methamphetamine)-assisted therapy (AT) for moderate to severe PTSD (posttraumatic stress disorder): a randomized, placebo-controlled phase 3 trial, indicated 71.2 per cent of participants in the MDMA-AT group no longer met the criteria for PTSD after receiving three dosing sessions, together with therapy, delivered approximately one month apart -- further underscoring the importance and potential effectiveness of MDMA for the treatment of PTSD. Just as important, therapy alone in the study showed substantial results, with 47.6 per cent of the placebo group no longer meeting the PTSD criteria posttreatment, after receiving therapy for approximately three months.

With its established clinic network, Numinus stands ready to offer MDMA-assisted therapy pending appropriate regulatory approvals. The company has already initiated a comprehensive practitioner training pathway to train qualified professionals to meet the demand for MDMA-assisted therapy.

"This marks a milestone for both MAPS and the entire psychedelic-assisted therapy community," said Payton Nyquvest, founder and chief executive officer. "By further demonstrating the effectiveness of MDMA-assisted therapy for the treatment of PTSD, many in the industry view this as the final step before the treatment undergoes FDA [United States Food and Drug Administration] review for approval and the promise of wider patient access."

Mr. Nyquvest continued: "At Numinus, we're well positioned to welcome clients looking for relief from PTSD, and expect to be able to add MAPS's MDMA-assisted therapy protocol to our existing service offering within our clinic network following regulatory approval. We believe there is a significant number of people who can benefit from these important treatments. Moreover, for providers are eager to adopt this treatment modality to serve their clientele, Numinus offers those practitioners a pathway through its existing training program. With mental wellness clinics across North America, Numinus is taking a leading role in facilitating access to a growing list of psychedelic-assisted therapies."

Additional information regarding the MAPS clinical trial results

This multisite, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of MDMA-assisted therapy compared with placebo, with identical therapy in participants with moderate to severe posttraumatic stress disorder. Participants were ethnoracially diverse, which is important because gender-diverse and transgender individuals, ethnoracial minorities, first responders, military personnel, veterans and victims of chronic sexual abuse have a disproportionately higher risk of developing PTSD due to disparities in trauma exposure. These diverse populations are historically underrepresented in clinical trials. The full text is available on-line.

About Numinus Wellness Inc.

Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model -- including psychedelic production, research and clinic care -- is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, the company is leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

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