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Canadian Company Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

Published: Jun 27, 2022   

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Canadian Company Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

Optimi Health Corp has submitted a request with Health Canada for an amendment to its Controlled Substances Dealer’s Licence.

The amendment would enable Optimi to synthesize, process and distribute pharmaceutical grade 3,4-Methylenedioxymethamphetamine (“MDMA”), among other substances, at its Princeton, British Columbia facility.

With Optimi’s main capital expenditure now completed, it will move to expand its offering to encompass a wide variety of synthetic psychedelics through its market-leading EU-GMP cultivation and analytical laboratory. The move aligns with Optimi’s planned year of commercialization, allowing the Company to maximize revenue-generating opportunities through standardized psychedelic drug testing, R&D, and product development through approved clinical trials and exemption-based applications.

Ongoing large-scale studies, including Phase III clinical trials investigating MDMA conducted by the Multidisciplinary Association for Psychedelic Studies (“MAPS”), along with more recent decriminalization initiatives announced in the Province of British Columbia, have generated significant unmet demand for these substances for research purposes.

Optimi Health Chief Science Officer Justin Kirkland stated that, “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. 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.”

Mr. Kirkland elevates Optimi as an industry leader utilizing his drug manufacturing expertise shown in his USPTO awarded Bromo-LSD manufacturing patent sold in 2020 for C$10M and GMP regulatory knowledge from his role as CEO at FDA registered Fristoe Pharmaceuticals.

Optimi CEO, Bill Ciprick, says the Company’s EU-GMP operational footprint and throughput capacity is unmatched in North America and would likely take new entrants into the space 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 concluded.

The Company’s amendment application to Health Canada also includes:

    • 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”).


    This article has been republished from materials provided by Optimi Health. Note: material may have been edited for length and content. For further information, please contact the cited source.

     

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