Pharmaceutical

Policy amendment allows practitioners to request access to psychedelic drugs for patients with serious or life-threatening conditions on a case-by-case basis

Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI), a leader in psychedelics-focused mental healthcare, commends Health Canada's leadership for amending the Special Access Programme (SAP) to allow physicians to request patient access to psychedelic treatments, such as MDMA- and psilocybin-assisted therapy, for serious treatment-resistant or life-threatening conditions on a case-by-case basis. The amendment has the potential to positively affect the lives of people experiencing serious mental health conditions when other therapies have failed, are unsuitable or are unavailable in Canada .

"Amending the SAP and righting a historical wrong based on stigma highlights Canada's commitment to making psychedelic-assisted therapies a possibility for the many Canadians who struggle with mental wellness," said Payton Nyquvest , Founder and CEO, Numinus. "While we believe this is only the beginning of greater change to come, it signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic medicine. I am proud of our team who have had a longstanding role in advocating for this reform."

Health Canada's amendment recognizes a growing body of research, including the work that Numinus' clinical and research teams are completing, that has consistently shown the efficacy of psychedelic-assisted psychotherapy to treat a broad range of mental health conditions that are currently extremely difficult to treat with conventional therapies. According to Health Canada, access will be provided when there is sufficient data to support the safety and efficacy of the drug for the specific condition of the patient and will be available once the regulations come into force when the amendment is published in the Canada Gazette, which is anticipated on January 5 th , 2022.

"Revising the SAP to allow for a case-by-case consideration of the suitability of psychedelic-assisted psychotherapy is a critical first step towards patients having access to these potentially transformative, safe and effective treatments when other treatments have failed," said Dr. Lindsay Farrell , Vice President of Indigenous Initiatives and Reconciliation, Numinus. "Nevertheless, new pathways ensuring equitable access to psychedelic-assisted therapies for racialized, marginalized, underserved populations and Indigenous Peoples are also urgently needed, especially in the context of sacred plants that have been used in cultural practices by Indigenous Peoples since Time Immemorial .  We encourage the federal government to create regulations that acknowledge and honour the traditional use of certain sacred plants and create pathways for safe and equitable access."                                                   .

Added Dr. Evan Wood , Chief Medical Officer, Numinus: "We applaud Health Canada and hope this is the first in a series of regulatory reforms where the federal government can provide leadership with the best interests of Canadians in mind.  We know that, with all currently illegal drugs, doing nothing only creates public and patient safety concerns that can best be addressed by thoughtful regulatory approaches."

The Special Access Programme (SAP)

The SAP was designed to allow people access to new, potentially life-saving medications before they are formally approved for routine use in healthcare.

Historically, psychedelic medications have been ineligible for Special Access Programme applications. The regulatory amendment, which is expected to come into force on January 5 th , 2022, will enable Canadian physicians to apply for psychedelic therapies in a similar process as to how other investigational medications are accessed prior to formal drug approval.

A substantial body of research, including the completion of a growing number of randomized clinical trials, has demonstrated that psychedelic-assisted therapies using psilocybin and MDMA appear to be highly effective approaches for the treatment of a host of potentially life-threatening mental health conditions, including treatment-resistant depression, post-traumatic stress disorder (PTSD), substance use disorders, and severe anxiety associated with terminal diagnoses.

In addition to allowing ongoing access for research participants after a clinical trial is complete, the SAP enables physicians to apply for access on behalf of qualifying Canadians who have serious or life-threatening conditions.

Patients cannot apply to the SAP directly, and only licensed healthcare practitioners who are authorized under the laws of a province or territory to treat patients with a prescription drug may file requests through the SAP.

About Numinus

Numinus Wellness (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 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, 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

This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", , "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's limited operating and profitability track record; dependence on management; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.

Neither the TSX  Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Cision View original content: https://www.prnewswire.com/news-releases/numinus-wellness-commends-health-canada-on-special-access-programme-amendments-to-restore-potential-access-to-psychedelic-medicines-301450137.html

SOURCE Numinus Wellness Inc.

Cision View original content: http://www.newswire.ca/en/releases/archive/December2021/22/c7446.html

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