Psychedelic therapies including psilocybin are increasingly being considered for their remedial and medical benefits by health organizations across North America.
Across North America, psychedelic therapies are increasingly being considered for their remedial benefits.
The heavy social and economic burdens associated with rising rates of mental illness in the general population have led researchers to explore new ways to target the root causes of these issues. Across North America, a number of leading regulatory authorities such as Health Canada and the United States Food and Drug Administration (FDA) have begun to recognize the potential for psychedelics to provide remedial mental health benefits. While research is required to pinpoint the effects and mechanisms of specific compounds, initial trials have shown the potential for psychedelic therapies to expand the modern medical toolkit.
Psychedelic compounds showing potential
A number of research studies have progressed in their exploration of psychedelic-assisted therapies, including the use of psilocybin, MDMA, DMT, mescaline, and other compounds. In North America, the modern embrace of psychedelic-assisted therapies and their remedial potential has been handled cautiously but steadily by leading medical authorities. In the United States, the FDA recognized the potential benefits of MDMA as far back as 2017 when it assigned Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder (PTSD).
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Following the announcement of the designation, the FDA and the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) reached an agreement to design Phase 3 trials of MDMA-assisted psychotherapy for patients with severe PTSD. “For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way,” said Rick Doblin, Founder and Executive Director of MAPS. “Now that we have an agreement with the FDA, we are ready to start negotiations with the European Medicines Agency.”
In 2019, the FDA assigned its Breakthrough Therapy Designation to another psychedelic compound, psilocybin, which is present in some species of mushrooms, for the treatment of major depressive disorder (MDD). This enabled the Usona Institute to launch a Phase 2 clinical trial including approximately 80 participants across seven sites in the United States.
“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients,” said Charles Raison, MD, Director of Clinical and Translational Research at Usona. “What is truly groundbreaking is the FDA’s rightful acknowledgment that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies.”
Independent research centers in the United States have also begun to explore the remedial potential of psychedelic-assisted therapies. In 2019, Johns Hopkins University announced the creation of the Center for Psychedelic and Consciousness Research with the goal of researching how psychedelics affect behavior, brain function, brain biology, learning, memory, and mood. The university intends to learn more about these mechanisms in order to explore the use of psilocybin for diseases such as opioid addiction, Alzheimer’s disease, post-treatment Lyme disease syndrome, depression and eating disorders.
Emerging psychedelic therapies in Canada
In Canada, the country’s leading federal health authority, Health Canada, has similarly embraced the medical potential of psychedelic therapies, including psilocybin. In July 2019, Health Canada provided healthcare company Numinus (TSXV:NUMI) a licence under the Controlled Drugs and Substances Act to test, possess, buy and sell MDMA, psilocybin, psilocin, DMT and mescaline. Health Canada has since granted a licence amendment that allows Numinus to produce and extract psilocybin from mushrooms.
Under the terms of the company’s amended licence, Numinus will develop proprietary extraction methods for naturally-sourced psilocybin. In addition to providing a source of natural psilocybin as an alternative to the currently available synthetic products for research purposes, this will also enable the exploration of other compounds within “magic mushrooms” which may have therapeutic benefits.
“We are proud to be at the forefront of a new therapeutic category by advancing evidence-based science with wellness and personal connection at its core,” said Numinus CEO Payton Nyquvest. “Numinus is the only publicly-traded company in Canada approved to develop a consistent psilocybin extraction method from naturally-produced mushrooms at a time when alternative therapeutic methods are increasingly being investigated and demand from clinical research is growing.”
At its 7,000-square-foot facility in Nanaimo, B.C., the company intends to develop a proprietary extraction method from mushrooms to allow for consistent dosing and application of naturally produced psilocybin. Senior research scientists Dr. Kristina Grotzinger and Dr. Bernd Keller will lead the project with the goal of establishing supply agreements with leading research organizations and health authorities for clinical and therapeutic purposes.
Supporting its psychedelic research operations, the lab has established and growing revenue from its B2B cannabis services, enabled by its Health Canada license to analyze and test cannabis.
“Revenue from our existing cannabis testing operations provides us a foundation for growth, which I feel differentiates us from others in the psychedelics space,” said Nyquvest. “This offering will be strengthened by a standard cannabis processing and extraction licence from Health Canada which the company expects to be granted in Q4 2020.”
Numinus’ eventual goal is to establish a network of world-class therapeutic centers across North America. In addition to its existing clinic which is prototyping standardized, profitable systems and processes for delivering mind-body wellness therapies, Numinus intends to create a purpose-built facility in Vancouver, B.C. that is expected to facilitate the safe and legal use of psychedelic therapies for medical purposes when regulated.
A number of leading health authorities across North America have recognized the potential for psychedelic therapies such as psilocybin and MDMA to treat challenging mental health conditions such as PTSD, depression and addiction. Demonstrated by the increasing number of organizations working worldwide to establish safe and effective methods of extracting, dosing, and delivering psychedelic compounds, psychedelic-assisted therapies appear to have significant potential to join mainstream modern medicine in enabling mental health and wellness.
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