Numinus Wellness Inc. (TSX-V:NUMI, OTC:LKYSF), a leader in psychedelics-focused mental healthcare, has applauded Health Canada's leadership in amending the Special Access Programme (SAP) to allow physicians to request patient access to psychedelic treatments.
The amendment includes MDMA and psilocybin, among other drugs. Once the amendment is published in the Canada Gazette, potentially on January 5, 2022, practitioners could request access to restricted drugs on behalf of patients with serious or life-threatening conditions in instances where other therapies have failed or are unsuitable. This would work strictly on a case-by-case basis.
Numinus noted that 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 unavailable in Canada.
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"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," Numinus CEO Payton Nyquvest said in a statement.
"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," he added.
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 given when there is data to support the safety and effectiveness 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, 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.
"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. 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."
Meanwhile, Numinus Chief Medical Officer Dr Evan Wood commended Health Canada and hoped “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," added Dr Wood.
The regulatory amendment will enable Canadian physicians to apply for psychedelic therapies in a similar manner to how other investigational medications are accessed prior to formal drug approval.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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