Optimi Health Corp., a Canadian company that specializes in controlled psychedelic substances, has received an amendment to its Health Canada licence that allows it to increase the quantities of MDMA, MDA, and 2C-B that it can produce and research.
A Milestone for Optimi and the Psychedelic Industry
The amendment, which was granted on January 16, 2024, is a significant achievement for Optimi and the psychedelic industry, as it enables the company to produce and research more of these substances that have shown potential for treating various mental health conditions.
According to the amendment, Optimi can now produce the following amounts of these substances under subsection J.01.059 (4) of Part J of the Food and Drug Regulations:
- N-Methyl-3,4-Methylenedioxy Amphetamine (MDMA) – from 2kg to 20kg.
- 3,4-Methylenedioxyamphetamine (MDA) – from 1kg to 2kg.
- 4-Bromo-2,5-Dimethoxybenzene Ethanamine (2C-B) – from 400g to 4kg.
MDMA, also known as ecstasy or molly, is a synthetic drug that alters mood and perception. It is currently being investigated for its potential to treat post-traumatic stress disorder (PTSD), social anxiety, and other disorders.
MDA, also known as sassafras or sass, is a similar drug to MDMA, but with more psychedelic effects. It is also being studied for its possible therapeutic benefits for depression, anxiety, and addiction.
2C-B, also known as nexus or bees, is a synthetic psychedelic drug that produces visual and sensory effects. It is being explored for its potential to enhance creativity, empathy, and spirituality.
Optimi’s Vision and Strategy
Optimi’s CEO, Bill Ciprick, expressed his excitement and gratitude for the amendment, stating, “This marks a pivotal achievement in Optimi’s strategic licensing plan, positioning us with one of the most robust licensing portfolios globally. It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances.”
GMP, or Good Manufacturing Practice, is a system of quality assurance that ensures that products are consistently produced and controlled according to the highest standards.
Optimi is also preparing for the possible approval of MDMA by the U.S. Food and Drug Administration (FDA) in 2024, which could open up a huge market for the drug as a prescription medicine.
Optimi’s strategic licensing plan for 2024 includes obtaining a Drug Master File (DMF) and a Drug Establishment Licence (DEL) from Health Canada. These documents will demonstrate Optimi’s compliance and transparency with the regulatory authorities and enable it to deliver high-quality APIs and controlled substances that meet global standards for pharmaceutical manufacturing and control.
Optimi is also one of the few companies in the world that has a licence to produce natural psilocybin, the active ingredient in magic mushrooms, which is another promising psychedelic substance for mental health treatment.
Optimi’s mission is to optimize the health and wellness of people through the use of natural and synthetic psychedelic substances, backed by scientific research and innovation.
