Numinus and Multidisciplinary Association for
Psychedelic Studies collaboration
will conduct follow-on Compassionate Access trial in real-world
setting in Vancouver,
VANCOUVER, May 10, 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, today congratulates
the Multidisciplinary Association for Psychedelic Studies (MAPS)
and the MAPP1 trial study team for their announcement of results
from the Phase 3 randomized clinical trial of MDMA-assisted therapy
for the treatment of severe post-traumatic stress disorder
The trial involved 90 participants with chronic PTSD. It
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.
The results, published in the peer-reviewed medical journal
Nature Medicine, presented no serious safety concerns, and
confirmed earlier findings from MAPS' six completed Phase 2
clinical trials that demonstrated clear safety and efficacy of
"These Phase 3 results confirm the substantial efficacy and
safety of MDMA-assisted therapy for PTSD under the MAPS protocol,"
said Payton Nyquvest, Chief
Executive Officer of Numinus. "We hope this evidence encourages
health regulators to urgently consider policy changes that broaden
safe and evidence-based access not only to MDMA but other
psychedelic-assisted therapies for mental health care."
Phase 3 is the final phase of research required by regulators,
such as Health Canada and the U.S. Food and Drug Administration
(FDA), before deciding whether or not to approve MDMA as a legal
prescription treatment for PTSD.
Bringing clinical results into a real-world context
Numinus and MAPS Public Benefit Corporation (PBC), a
wholly-owned benefit subsidiary of MAPS, announced in December 2020 their collaboration on a
compassionate access trial to deliver MDMA-assisted psychotherapy
for PTSD for individuals with treatment-resistant PTSD who are
unable to access MDMA-assisted therapy through a Phase 3 trial. Key
milestones have since been announced, including the finalization of
treatment protocols, training of trial therapists and appointment
of lead investigators. The trial is currently in pre-implementation
phase and will move into implementation in summer 2021.
"Our compassionate access trial seeks to provide additional
safety data to Health Canada that we expect will add to this
impressive Phase 3 data to support eventual approval of
MDMA-assisted psychotherapy for Canadians with PTSD," said Dr.
Devon Christie, Medical and
Therapeutics Services Director of Numinus and Principal
Investigator of the compassionate access trial by Numinus and MAPS.
"The results highlight the importance of continued efforts such as
those by Numinus to bring these treatments to the
Millions are affected globally by PTSD. Canada showed the highest incidence of PTSD in
a large-scale study of 24 countries that indicated 1 in 11
Canadians will suffer from PTSD in their lifetime.¹ Current mental
health treatments often present limited benefits, poor uptake and
negative side effects while requiring chronic medication
utilization. Psychedelic-assisted therapy is becoming more
mainstream and increasingly accepted by US and Canadian regulators,
and has been validated by academic and industry research.
MDMA-assisted therapies for PTSD increasingly demonstrate efficacy,
including one study showing higher safety and greater effectiveness
compared to two common antidepressants² and another study showing
both substantial clinical impact and potential cost-savings of
millions of dollars per year.³
Media, please note video content: Dr. Devon Christie provides her thoughts on the
critical importance of the MAPS Phase 3 trial results, and further
information on the upcoming Phase 2 compassionate access trial
undertaken by Numinus and MAPS PBC in Canada.
1. Post–Traumatic Stress Disorder in Canada. CNS Neuroscience & therapeutics.
13 Aug 2008.
2. Breakthrough for Trauma Treatment: Safety and Efficacy of
MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline.
Frontiers in Psychiatry. 12 Sep
3. The cost-effectiveness of MDMA-assisted psychotherapy for the
treatment of chronic, treatment-resistant PTSD. PLOS ONE.
14 Oct 2020.
Numinus Wellness (TSX-V: NUMI) empowers 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,
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SOURCE Numinus Wellness Inc.