First-of-its-kind policy
amendment will allow legal access to evidence-based treatments to
those in need before formal drug approval
VANCOUVER, BC, Dec. 11, 2020 /CNW/ - 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:
http://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.
____________________
|
[CS1]
http://www.gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html#nb2
|
SOURCE Numinus Wellness Inc.