Policy amendment allows practitioners to
request access to psychedelic drugs for patients with serious or
life-threatening conditions on a case-by-case basis
VANCOUVER, BC, Dec. 22, 2021 /CNW/ - 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 5th, 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 5th, 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.
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SOURCE Numinus Wellness Inc.