Numinus and Multidisciplinary Association for Psychedelic Studies collaboration will conduct follow-on Compassionate Access trial in real-world setting in Vancouver, Canada
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 (PTSD).
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 MDMA-assisted therapy.
“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 mainstream.”
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 2019.
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.
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SOURCE Numinus Wellness Inc.