Numinus Wellness Receives Health Canada Approval for Study into Group Model for MDMA-Assisted Therapy

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May 30, 2024, 07:00 ET

VANCOUVER, BC, May 30, 2024 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing traditional and innovative behavioral health treatments with a focus on safe, evidence-based psychedelic-assisted therapies, announces that Health Canada has approved the Company's Clinical Trial Application to examine the feasibility of a group model in MDMA-assisted psychotherapy enrolling trainee practitioners as participants.

The study aims to enhance comprehension of the ideal number of therapists needed to administer MDMA-assisted psychotherapy group sessions effectively. Additionally, the trial offers eligible trainees the chance to develop core competencies through observing seasoned therapists conduct MDMA-assisted psychotherapy sessions and legally experience MDMA themselves in a therapeutic setting as healthy research subjects.

"We are pleased to have received approval for this study, which will be the first of its kind to investigate the viability of a group therapy model, establish the best methods for MDMA group therapy, and add to the existing research supporting its safe use," said Payton Nyquvest, Numinus Founder and CEO. "Considering the growing body of research into the potential benefits of MDMA for treating severe mental disorders, such as PTSD, it's essential that medical professionals enhance their understanding of how best to administer it in a clinical environment."

The clinical trial is formally titled "Phase 1 Exploration of Feasibility and Optimal Therapist Numbers in Group Model MDM-Assisted Psychotherapy: A Study on Safety, Delivery, and Practitioner Training."

"This study could greatly improve therapist understanding of the effects of MDMA, therapist skills, and patient outcomes by offering practitioners a chance to gain crucial insights into different modalities of treatment," added Rick Doblin, PhD., an unpaid volunteer Numinus Strategic Advisor. "This will become important should MDMA treatment for PTSD receive FDA approval with a significant number of patients in need of care."

About Numinus

Numinus Wellness Inc. (TSX: NUMI) 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 research, clinic care and practitioner training – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Forward-looking statements

Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect" and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, including approval of MDMA-assisted therapy for any indication or at all; restrictions that may be placed on the use of MDMA by regulatory authorities; safety and efficacy of MDMA-assisted therapy; acceptance, uptake and commercialization of MDMA-assisted therapy; timing and completion of the clinical trial; availability of suitable subjects for the trial; and other risks that are set forth in our annual information form dated November 29, 2023 and available on SEDAR at www.sedarplus.ca. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. Numinus does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.

SOURCE Numinus Wellness Inc.