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First-of-its-kind policy amendment will allow legal access to evidence-based treatments to those in need before formal drug approval
Numinus Wellness Inc . ("Numinus" or the "Company") (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, commends Health Canada's leadership for its intention to revise the Special Access Programme (SAP) to permit access to MDMA and psilocybin-assisted psychotherapy. The intended SAP revision, announced today, will positively affect the lives of the many Canadians experiencing mental health conditions who have not responded to existing therapies.
Numinus' leadership has worked to inform Health Canada and to advocate for an evidence-based revision of the SAP regulations. Health Canada's announcement recognizes a growing body of research including a range of clinical trials that consistently highlight the potential patient benefit and breakthrough therapy status of MDMA and psilocybin-assisted psychotherapy for a large range of mental health conditions that are currently extremely difficult to treat with conventional therapies.
"Today's announcement from Health Canada is a milestone for the entire healthcare industry and one that highlights our country's commitment to making psychedelic-assisted psychotherapies an accessible reality for Canadians who have run out of options," said Payton Nyquvest , Founder, Chief Executive Officer, and Chair of Numinus. "For the millions of Canadians who continue to live with mental illness: we see you, we hear you, and with today's news, we look forward to a safe and accessible path to new ways of healing. We applaud Health Canada for taking this leadership position and commend the organizations and individuals who continue to advocate for this crucial change."
"Revising the SAP to allow for the safe use of MDMA and psilocybin-assisted psychotherapy is a critical step to helping address the huge treatment gaps that exist for a range of mental illnesses and substance use disorders. Today, Health Canada has signalled a commitment to both patients graduating from formal trials, and individuals who have no other treatment options," said Dr. Devon Christie , Medical Director at Numinus and a MAPS-trained therapist for the delivery of MDMA-assisted psychotherapy. "This intended change aligns with global ethical guidelines supporting early patient access to promising treatments in a safe and controlled setting."
Adds Dr. Evan Wood , Numinus Chief Medical Officer, "Treating emerging therapies for mental health disorders differently than other investigational medications is not ethical or justifiable. Indeed, granting pre-approval access through the SAP enables care providers to gain critical experience with service delivery while also informing future Health Canada approval processes."
The Health Canada Special Access Programme (SAP)
The Health Canada SAP was designed to allow Canadians access to new, potentially life-saving medications before they are formally approved for routine use in health care.
Historically, psychedelic medications have been ineligible for Special Access Programme applications. The proposed regulatory change will enable Canadian patients to apply for psychedelic therapies in a similar process 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 psychotherapies 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, posttraumatic 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 were not research participants.
Public Consultation
Health Canada's Notice of Intent regarding the SAP will be open for public consultation and comments for the next 60 days, and Numinus strongly encourages the community to weigh in on the benefits of the revision. View the notice here: https://www.gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html#nb2
To share comments and thoughts related to the SAP, please email hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca
About Psychedelic-Assisted Psychotherapy
Psychedelic-assisted psychotherapy has gained a great deal of interest within the medical community and general public as research results demonstrate its superior effectiveness for a range of mental health conditions. These results are contributing to a paradigm shift in both the understanding and treatment of mental health conditions.
Numinus has announced plans to embark upon open-label compassionate access clinical trials of psilocybin-assisted psychotherapy for substance use disorders and MDMA-assisted psychotherapy for PTSD , enabling it to implement, test and refine optimal protocols for delivery before these therapies are widely accessible. This includes developing physical and human resource infrastructure more broadly to deliver psychedelic-assisted psychotherapy including for Special Access Programme patients.
Numinus is uniquely positioned to provide patients with MDMA and psilocybin-assisted psychotherapy under the expanded SAP revision based on its extensive work completed on developing protocols for psychedelic-assisted psychotherapy. The Company is also a leader in the industry as the first public entity in Canada to receive a licence to produce and extract psilocybin from mushrooms, the first to complete a legal harvest of psilocybe mushrooms using this licence and the holder of a Health Canada dealer's licence to import, export, possess, test and distribute MDMA, psilocybin and other psychedelics.
Applications for Numinus's compassionate access trials and for access under the SAP, pending approval, are not yet open. To be advised of the status and procedures for applications when available, register for Numinus's newsletter .
On behalf of the board of Numinus Wellness Inc.
Payton Nyquvest
President, Chief Executive Officer and Chair
About Numinus
Numinus Wellness Inc. (TSXV: NUMI) is a mental health and wellness company creating an ecosystem of solutions centred around safe, evidence-based, accessible psychedelic-assisted psychotherapy to help people heal and be well.
Numinus Health is dedicated to delivering innovative treatments to address physical, mental, and emotional health, through clinics and virtual services.
Numinus R&D is conducting implementation science and leveraging partnerships to beta-test and refine optimal models of psychedelic-assisted psychotherapy delivery, setting the stage for approved routine use in mental health and wellness care.
Numinus Bioscience is focused on developing testing methods and effective formulas for the evolving psychedelics space. Health Canada licences, scientific expertise, and new technologies facilitate ongoing innovation, and high-throughput contract services generate established revenue.
Learn more at numinus.ca , and follow us on Facebook , Twitter , and Instagram .
Forward Looking Statements
This news 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 of future performance, are "forward-looking statements." Forward-looking statements can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals licences and permits to operate and expand the Company's facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company's limited operating history and lack of historical profits; reliance on management; the Company's requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to 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 has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
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[CS1] https://www.gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html#nb2 |
SOURCE Numinus Wellness Inc.
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