VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a Canadian-based company licensed by Health Canada to produce natural, scalable, and accessible psychedelic and functional mushrooms for transformational human experiences, has received permission from Health Canada to manufacture and distribute additional psychedelic substances, most notably MDMA, under the amended terms outlined in its June 20, 2022 application to Health Canada.
Under the leadership of Chief Science Officer Justin Kirkland, Optimi will now act as wholesale supplier of MDMA and other synthetic psychedelic compounds to approved researchers and drug developers.
The Company is scheduled to begin production and analytical testing of MDMA this October in its recently completed EU-GMP pharmaceutical manufacturing facility.
Optimi CEO, Bill Ciprick, says the Company’s in-house capacity to produce a wide range of scalable formulations puts Optimi at the forefront of the commercial manufacturing and supply of psychedelics.
“From lab to market, Optimi has taken every step necessary to build its competitive position as a global leader in the manufacturing of EU-GMP compliant MDMA in North America, and we’ve done that through operational transparency and investing in smart infrastructure.”
He further added, “On compliance, quality, and scale, we have consistently demonstrated our plan to lead the industry in API synthesis and formulation, which gives our science and operations team the confidence to develop saleable psychedelic products that are supported by rigorous in-house Standard Operating Procedures (SOP),” said Ciprick.
The terms of the amendment took effect as of Friday, August 5, 2022, and will allow the Company to increase the overall output potential of its Princeton, British Columbia facility to better address the needs of the evolving psychedelic market as part of Optimi’s planned year of commercialization.
Since applying for the amendment in June, the Company has met with industry stakeholders, drug developers, and clinical trial researchers interested in exploring Optimi’s production capabilities, reaffirming the Company’s decision to proceed with this phase of its commercialization strategy.
In May 2022 it was reported by online publication, The Intercept, that the Joe Biden administration was anticipating FDA regulation of MDMA and psilocybin within the next two years and was “exploring the prospect of establishing a federal task force” to review the psychedelic ecosystem.
With 130 MDMA clinical trials currently listed between Canada and United States, and the prospect of the Biden Administration looking to regulate MDMA and psilocybin, Optimi is already preparing for future international and domestic regulatory movement that could positively impact the Company.
“The regulatory landscape in the U.S and Canada is always evolving, specifically with the Canadian government’s recent decision to decriminalize MDMA up to 2.5 grams in British Columbia,” said Optimi regulatory affairs advisor, Michael Kydd. “Governments often use incremental shifts in policy to test public sentiment, which sometimes triggers broader policy change down the road. Having a licence to produce EU-GMP MDMA at an unmatched scale will benefit the Company when we eventually see these wholesale policy changes,” added Kydd.
Optimi Health products are still being investigated through a clinically validated development program for the purpose of applying for market authorization. The safety and efficacy of our products has not been formally established.
In addition to MDMA, the Company now has Health Canada approval to manufacture and distribute additional substances including:
2-(2-chlorophenyl)-2- (methylamino)cyclohexanone (“Ketamine”);
Lysergic Acid Diethylamide (“LSD”);
4-Hydroxybutanoic Acid (“GHB”);
Salvia Divinorum, Salvinorin A; and,