Canadian companies send psilocybin package to Health Canada for pre-clinical trial application

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Vancouver-based companies Optimi Health and Numinus Wellness are one step closer to conducting clinical trials for psilocybin after submitting an information package to Health Canada.

With the assistance of the Impact Clinical Trials Accelerator at the University of Calgary, the companies announced they had submitted the application for review and comment. If approved, Numinus plans to develop an all-natural psilocybin capsule for use in Optimi’s human clinical trials.

The initial trial would focus on dosage before expanding into psilocybin treatments for a variety of health conditions.

“This is another important step for our commitment to the development of naturally sourced, evidence-based product formulations,” said Optimi chairman of the board JJ Wilson.

The information package included the investigational product’s chemical constituents, genotype, and formulation as well as procedures and processes to produce a consistent dosage from psilocybe mushrooms.

Optimi will retain 100 per cent ownership of the resulting all-natural psilocybin capsule and full intellectual property rights to its use, according to the release.

“Numinus is pleased to partner with Optimi on this important work and provide the expertise, licensed facility and specialized equipment required to quickly develop, formulate and rigorously test products derived from natural psilocybe sources and prepare them for Health Canada submissions and approvals,” said Sharan Sidhu, science officer and general manager of Numinus Bioscience.

Numinus operates a Health Canada-licensed lab and can legally possess, produce, and export a number of psychedelics, including ketamine and Lysergic acid diethylamide (LSD).

Optimi has also received a research exemption under Health Canada Food and Drug Regulations for the use of psilocybin and psilocin for scientific purposes.

Last week, Mind Medicine Inc. announced it was undergoing a new effort, dubbed Project Angie, to study how psychedelics, including LSD, can be used in treating pain.

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