Regulatory Approvals Place Numinus Lab at the Forefront of Global Psychedelics Research
Numinus Bioscience adds Ketamine and LSD to licence to produce, assemble and sell a wide variety of psychedelic compounds
Numinus Wellness Inc. (TSXV: NUMI), a global leader in supporting and expanding the safe, accessible and evidence-based use of psychedelic-assisted psychotherapies (PAP), has received new amendments under Canada’s Controlled Drugs and Substances Act that enhance the Company’s ability to lead psychedelics research and support the global psychedelics sector.
Numinus Bioscience, which operates a state-of-the-art research lab in British Columbia, Canada, recently received amendments to its federal licence to allow the possession, production, assembly, sale, export, and delivery for a wide variety of psychedelics including – for the first time – Ketamine and Lysergic acid diethylamide (LSD). The amendment also supports Numinus Bioscience’s role in these activities related to Mescaline, N,N-Dimethyltryptamine (DMT), N-Methyl-3,4,methylenedioxyamphetamine (MDMA), Psilocin and Psilocybin.
These amendments are not just exciting for Numinus and our researchers, but also for our partners, clients and potentially academic collaborators in the psychedelics space. The amendments dramatically expand the work we can do with a far larger group of psychedelics, and open up market-leading and revenue-generating opportunities for Numinus in R&D, psychedelic formulations, research and analysis. Moreover, we can now develop and implement standardized psychedelics testing on top of our existing high throughput capabilities, and formulate and produce psychedelic compounds in finished packaged products for clinical trials, clinical use under exemption, and export.Sharan Sidhu, Science Officer and General Manager for Numinus Bioscience
Among other valued-added services, the amendments enable Numinus Bioscience to pursue formulation and stability studies to assemble finished products for all approved psychedelics.
Previously, Numinus Bioscience conducted R&D and analytical testing on Psilocybe mushrooms. New amendments allow Numinus Bioscience to conduct all activities related to possession, production, sale, export, delivery and assembly for Psilocybe mushroom fruiting bodies, both whole ground and extracted, to stakeholders that possess a Section 56 exemption.
In addition, the new amendments allow Numinus Bioscience to increase the amount of Psilocin and Psilocybin produced at the lab from 505 grams to 1000 grams annually, consisting of 750 grams of Psilocybin and 250 grams of Psilocin. Health Canada has also acknowledged that the Company can continue to supply verified and validated Psilocybe mushroom spores and tissue culture that do not contain controlled substances to other licensed dealers and can be listed as a supplier. In coming quarters, Numinus Bioscience will prepare to offer the expanded suite of psychedelic products and services allowed by recent amendments.
“The approvals announced today mark a key milestone in advancing the integrated services model we are building to research and ultimately deliver quality therapies to people who may benefit, across the spectrum of mental health disorders,” said Payton Nyquvest, CEO, Numinus. “We know that currently available treatments for mental health disorders are often ineffective and can lead to major unwanted side effects. To date, clinical trials for professionally supervised psychedelic-assisted psychotherapies have shown safety and efficacy, with fewer and less severe side effects than conventional medicines.”
As the first public entity to legally cultivate and extract Psilocybe mushrooms under its dealers’ license, Numinus Bioscience is already a research leader in the psychedelics industry. The BC lab is licensed by Health Canada.
The safety and efficacy of psychedelic-assisted psychotherapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. 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 psychedelic-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.
Numinus Wellness Inc. (TSXV:NUMI) is a health care and research company creating psychedelic-centred solutions to treat mental illness, substance abuse and trauma.
Numinus Health delivers treatments through clinics and virtual services, with clinics in Vancouver and Montreal.
Numinus R&D develops clinical and therapeutic protocols to use in treatments, in collaboration with research partners and regulators.
Numinus Bioscience develops formulations and methods for a safe supply, using Health Canada licences, scientific expertise and cutting-edge technology.
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