Canadian Firm Seeks Approval to Manufacture MDMA and Other Psychedelics

A Canadian company that produces functional mushroom formulations for health and wellness has submitted a request to federal regulators that would allow it to manufacture MDMA and other synthetic psychedelic drugs. If the request made to Canada Health by Optimi Health seeking an amendment to its Controlled Substances Dealer’s license is approved, the company plans to manufacture MDMA, LSD, Mescaline, GHB and other psychedelics at its production facility in Princeton, British Columbia.

Optimi Health Corporation is a Canadian firm that produces psilocybin and other functional formulations at its two plants in British Columbia following the European Union’s standards for good manufacturing practices (EU-GMP). Operating under a vertically integrated business model, the company is engaged in the cultivation, extraction, processing, and distribution of functional and psychedelic mushroom products at its two facilities in Princeton, which cover a combined total of 20,000 square feet.

The company noted that with its major capital expenditures now completed, Optimi Health plans to expand its product offerings to include a wide variety of synthetic psychedelic compounds, leveraging its state-of-the-art cultivation facility and analytical lab in the process. The move aligns with the company’s transition to commercialization through standardized psychedelic drug research, testing, and product development via approved clinical trials and exemption-based applications.

Growing Market for Psychedelics

Optimi Health noted that ongoing large-scale studies including Phase III clinical trials into MDMA sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and a move to decriminalize drugs in British Columbia have led to an increased demand for psychedelics.

“Since our inception, Optimi has received a steadily increasing volume of inquiries related to the production of synthetic psychedelics from stakeholders within the sector, made all the more timely by recent developments,” Optimi Health chief science officer Justin Kirkland said in a statement from the company. “Our analytical laboratories were purpose-built to enable us to act as an EU-GMP compliant drug manufacturer for these interests, without in any way detracting from our primary goal of cultivating natural psilocybin.”

Optimi CEO Bill Ciprick said that the company’s EU-GMP compliant operational footprint and production capacity is unmatched in North America, adding that it would likely take new entrants into the psychedelics sector years and millions of dollars to meet Optimi’s scale and clinical efficiency.

“We have a strong idea of our position in the market and how the amendment fits with our strategic priorities,” said Ciprick. “We are filing this amendment following conversations with researchers and drug developers which have led to a high volume of requests for GMP-compliant synthetic psychedelics. The positive reports from trauma sufferers, including veterans groups, for whom substances such as MDMA might make a difference, mean that safe, scalable supply is going to be more crucial than ever to the success of psychedelic medicine.”

“As we continue with our planned year of commercialization, Optimi views the capacity to produce and distribute these substances as integral to our overall positioning and revenue generation within the sector’s supply chain,” Ciprick added.

The psychedelic drugs included in the Optimi request to Canadian regulators are N,N-Dimethyltryptamine (“DMT”); 3,4,5-trimethoxyphenethylamine (“Mescaline”); 2-(2-chlorophenyl)-2- (methylamino)cyclohexanone (“Ketamine”); Lysergic Acid Diethylamide (“LSD”); 1-(1-phenylcyclohexyl)piperidine (“Phencyclidine”); 4-Hydroxybutanoic Acid (“GHB”);  4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole (“Harmaline”); 4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol (“Harmalol”); Salvia Divinorum, Salvinorin A; and, 4-Bromo-2,5-Dimethoxybenzeneethanamine (“2C-B”).

British Columbia to Decriminalize Drugs

Last month, the Canadian federal government announced that it had approved a request from British Columbia to decriminalize possession of street drugs including heroin, fentanyl, cocaine, and methamphetamine for three years.

“Eliminating criminal penalties for those carrying small amounts of illicit drugs for personal use will reduce stigma and harm and provide another tool for British Columbia to end the overdose crisis,” federal Minister of Mental Health and Addictions Carolyn Bennett said in a statement quoted by Reuters.

Late last year, provincial officials requested an exemption from enforcing the federal Controlled Drugs and Substances Act to test the impact decriminalization will have on British Columbia’s ongoing epidemic of overdose deaths. Under the plan, personal possession of up to a cumulative total of 2.5 grams of opioids, cocaine, methamphetamine, and MDMA will not result in an arrest, citation, or confiscation of the drugs. The limited drug decriminalization plan does not apply at airports, schools, and to members of the Canadian military, however.

“This is not legalization,” Bennett told reporters at a news conference in Vancouver. “We have not taken this decision lightly.”

Under the plan, possession of larger amounts of the drugs and the sale or trafficking will remain against the law. The limited decriminalization test program will begin on January 31, 2023, and continue until January 31, 2026.