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Canadian Firm Seeks Approval to Manufacture MDMA and Other Psychedelics

Canadian firm that makes functional mushrooms for the purpose of health and well-being has asked federal regulators for permission to make MDMA. 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). The company operates under a vertically integrated model and is involved in the cultivation and extraction of functional and psychoedelic mushrooms products. It has two plants in Princeton that cover an area of approximately 20,000 feet.

Optimi Health noted that its capital investments have been completed. The company plans to increase its product offering to include a variety of synthetic psychedelic substances, using its state-of the-art cultivation facility, and analytic lab. 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 reported that there has been an increase in demand for psychedelics, thanks to ongoing large-scale research including the Phase III clinical trials of MDMA funded by Multidisciplinary Association for Psychedelic Studies.

“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 is to decriminalize drug use

The Canadian federal government approved last month a British Columbia request to make possession of heroin, methamphetamine, fentanyl and cocaine illegal 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. The plan allows personal possession up to 2.5 grams each of heroin, cocaine, methamphetamine and MDMA. This will prevent the drug from being confiscated, cited, or arrested. However, the limited drug decriminalization program does not apply to schools and airports.

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

According to the plan, the possession and sale of large amounts of drug will be prohibited. Beginning January 31, 2023 and continuing until January 31, 20,26, the limited decriminalization program will be in effect.