Approval Marks Numinus' First use of
Psilocybin-Assisted Therapy Treatment Outside of Clinical
Trials
VANCOUVER, BC, May 16, 2022
/CNW/ - Numinus Wellness Inc. ("Numinus") (TSX: NUMI) (OTC:
NUMIF), a mental health care company advancing innovative
treatments and safe, evidence-based psychedelic-assisted therapies,
today announced that Health Canada has approved Numinus'
application to complete psychedelic-assisted therapy using
psilocybin to treat an applicant with treatment-resistant
depression. This is Numinus' first psilocybin-assisted therapy
treatment outside of ongoing clinical trials, and among the first
to use of this regulatory mechanism through Health Canada's Special
Access Program ("SAP"), which was amended January 5th, 2022 to include access to
psychedelic compounds on a case-by-case basis.
Psilocybin-assisted therapy has shown a great deal of promise in
treating depression, as demonstrated in recent clinical trials and
studies.
"I am proud that Numinus is working with Health Canada to help
Canadians with mental health challenges in ways that were not
previously available, including using psilocybin-assisted therapy
through Health Canada's SAP," says Payton
Nyquvest, Founder and CEO, Numinus. "The SAP recognizes a
growing body of research that has consistently shown the efficacy
of psychedelic-assisted psychotherapy to treat a broad range of
mental health conditions that are extremely difficult to treat with
conventional therapies. We hope that our first psilocybin-assisted
therapy treatment is the beginning for more opportunities for
Canadian patients to obtain safe access to treatment and care in
the mental health sector through psychedelic medicine."
The psychedelic-assisted therapy treatment will take place at
one of Numinus' Montreal clinics,
consisting of psilocybin-assisted therapy including several
preparatory and integration therapy sessions, medical consults and
one psilocybin-dosing session. All practitioners involved in the
treatment have been trained through Numinus' proprietary
psilocybin-assisted therapy protocol and Numinus will partner with
Psygen Labs, an approved Health Canada supplier, to provide the
synthetic psilocybin to be taken orally during the dosing
session.
Dr. Andrew Bui-Nguyen, Numinus'
Québec regional medical director, who completed the application,
said: "Numinus has been working with this applicant through other
available services over an extended period and we are proud that we
can now provide this deeply important treatment. To our knowledge,
this is the first Health Canada SAP approval for
psilocybin-assisted therapy for someone suffering from treatment
resistant depression in Québec, and the first time our Numinus team
will provide this treatment outside of the clinical trial
setting."
To be considered for the SAP program, an applicant must have a
serious or life-threatening condition where conventional treatments
have failed, are unsuitable or are not available in Canada. As they are approached by treatment
resistant patients who meet this criteria, Numinus-affiliate
physicians plan to make additional applications for clients
suffering from a range of mental health conditions in BC and
Québec.
About Numinus
Numinus Wellness 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
Statements and other information contained in this press
release about anticipated future events, including but not limited
to Numinus' anticipated psychedelic-assisted therapy treatments and
additional applications under the SAP program, 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. Forward-looking
statements are based on estimates and opinions of management at the
date the statements are made and, although considered reasonable by
management at the time of preparation, may prove to be incorrect
and actual results and future events could differ materially. There
can be no assurance and the reader is cautioned that assumptions
used in the preparation of any forward-looking information may
prove to be incorrect. Events or circumstances may cause actual
results to differ materially from those predicted, as a result of
numerous known and unknown risks, uncertainties, and other factors,
many of which are beyond the control of the Company.
Forward-looking statements contained in this news release are
expressly qualified by this cautionary statement. The Company 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.
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content:https://www.prnewswire.com/news-releases/numinus-wellness-receives-health-canada-special-access-program-applicant-approval-to-provide-psychedelic-assisted-therapy-treatment-301547735.html
SOURCE Numinus Wellness Inc.