Real-world study expands access to
MDMA-assisted therapy for patients with PTSD and concurrent
disorders and will provide data on a regulated model for
MDMA-assisted therapy
VANCOUVER, BC, July
12, 2021 /CNW/ - Numinus Wellness Inc. ("Numinus" or
the "Company") (TSXV: NUMI), a mental health care company
advancing innovative treatments and safe, evidence-based
psychedelic-assisted therapies, is pleased to announce that Health
Canada has cleared the MAPS-sponsored single-arm,
open-label safety and feasibility study
evaluating MDMA-assisted therapy for post-traumatic stress
disorder (PTSD). This study is being pursued in collaboration
with MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned
subsidiary of the Multidisciplinary Association for
Psychedelic Studies (MAPS), the leading developer of MDMA-assisted
therapy training programs, treatment protocols and research.
"We are thrilled that Health Canada has issued its No Objection
Letter allowing this important study to proceed and, in doing
so, potentially advance Canada
toward a legal, regulated system for MDMA-assisted therapy," said
Payton Nyquvest, CEO of Numinus. "At
Numinus, we are focused on expanding patient access to
psychedelic-assisted therapies such as MDMA for PTSD, and
we are gratified that our study will provide safety and
outcome data to regulators to support integration of this treatment
into mainstream mental health care."
This study has advanced through the pre-implementation
stage at Numinus' Vancouver clinic
and has now received the required federal regulatory approval.
Study preparations are now transitioning into the final stages
of training staff, importing medication and obtaining ethical
approval to allow the recruitment of participants according to
COVID-19 public health protocols. During the study, research,
medical and therapist staff at Numinus will collect data on
the safety and effectiveness of MDMA-assisted therapy to
inform Health Canada and support making MDMA-assisted
therapy available to individuals living with PTSD in
Canada.
Through the collaboration and study activities, Numinus
seeks to create access for patients with no other treatment options
and establish the physical, human resource and other infrastructure
required to scale up access to MDMA-assisted therapy if federal
approvals are ultimately in place.
"As research into MDMA-assisted therapy grows, it is critical
that we develop data on outcomes from a diverse, real-world array
of clinical environments," said Amy
Emerson, CEO of MAPS PBC. "Clinical studies conducted
for the purpose of regulatory approval often address research
questions focusing on safety and efficacy of the treatment. This
collaborative demonstration study with Numinus will build upon
MAPS-sponsored multi-site studies which enrolled some Canadian
participants and will provide new and comprehensive information
about the effectiveness of MDMA-assisted therapy for populations
with PTSD and concurrent disorders."
Dr. Devon Christie, Numinus
Medical and Therapeutic Services Director, will serve as the
study's Qualified Investigator and as a study therapist. Dr.
Christie is a family physician with a focus in multidisciplinary
pain management and a certified Relational Somatic Therapist.
She is MAPS-trained in the delivery of MDMA-assisted therapy
for PTSD.
"Health Canada should be
recognized for its ongoing leadership through its support of this
study," said Dr. Christie. "At our Vancouver clinic, we have spent months
establishing the physical, technical, clinical and human resource
infrastructure needed to move the study forward and ultimately
foster greater access to MDMA-assisted therapy."
New trial builds on strong MAPS Phase 3
results
In May 2021, MAPS announced
results from its Phase 3 randomized clinical trial that confirmed
the substantial efficacy and safety of MDMA-assisted therapy for
PTSD under the MAPS protocol. The trial demonstrated that 88% of
participants who received three controlled and supervised
MDMA-assisted therapy sessions experienced a clinically significant
reduction in symptoms, with 67% no longer qualifying for PTSD
diagnosis in comparison to 32% of participants randomized to
placebo. Study participants had PTSD diagnoses from a range of
causes, including combat-related events, accidents, abuse, sexual
harm and developmental trauma.
Note
The safety and efficacy of MDMA-assisted therapy is currently
under investigation. It has not yet been approved by Health Canada
or the FDA, does not work for everyone, and carries risks even in
therapeutic settings. These statements are no guarantee of future
Health Canada or FDA approval or availability of MDMA-assisted
therapy. These statements necessarily involve known and unknown
risks and uncertainties, which may cause actual outcomes to differ
materially from projections.
Health Canada recommends
open-label pragmatic clinical trials when drug manufacturers
anticipate exceptional demand for a drug, "to meet the needs of
patients not eligible for enrollment in other pivotal
trials" (Special Access Program for Drugs: Guidance document
for industry and practitioners, Published 2020-10-14). This
program is not related to the U.S. FDA's Breakthrough Therapy
designation nor the Expanded Access Program,
sometimes referred to as "compassionate use."
About Numinus
Numinus Wellness (TSX-V: 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 Wellness 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 abuse. 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 numinus.ca, and follow us on Facebook, Twitter,
and Instagram.
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SOURCE Numinus Wellness Inc.