- Optimi Health Corp. (OPTI) has completed the production of its proprietary preclinical MDMA drug candidate OPTI-MHCL
- OPTI-MHCL was manufactured in accordance with GMP protocols led by Chief Science Officer Justin Kirkland at the company’s lab in Princeton, British Columbia
- Optimi Health Corp. is a drug manufacturer and formulator licensed by Health Canada to produce and supply natural, GMP-grade psilocybin, synthetic psychedelic substances, and functional mushrooms that focus on the health and wellness markets
- Optimi Health Corp was up 4.17 per cent, trading at $0.25 at 13:47 ET
Optimi Health Corp. (OPTI) has completed the production of its proprietary preclinical MDMA drug candidate OPTI-MHCL.
The OPTI-MHCL is for use in drug development, clinical trials, and individual patients authorized by Health Canada’s Special Access Program and Australia’s recently announced Authorized Prescriber Scheme.
The production of OPTI-MHCL was made using the company’s proprietary method and makes Optimi the only publicly-listed psychedelics company licensed by Health Canada to
possess, produce, assemble, sell, and supply its formulation in patient-ready encapsulated doses across global markets.
OPTI-MHCL was manufactured in accordance with GMP protocols led by Chief Science Officer Justin Kirkland at the company’s lab in Princeton, British Columbia and was validated after Kirkland achieved consistent results over multiple batches.
In addition to on-site testing, Optimi submits all of its products to third-party laboratories for independent analysis to ensure the highest possible purity and suitability for OPTI-MHCL’s anticipated universal use.
“I am proud to say that we now have an optimized route for the delivery of MDMA using our own in-house technology, which guarantees stable production and quality,” said Chief Science Officer Justin Kirkland.
“We feel our proprietary MDMA is the way of the future, and this unique offering can position us as the number one supplier globally,” he added.
OPTI-MHCL is available for distribution to licensed entities under the terms of an amendment to the company’s Controlled Substances Dealer’s Licence.
“With the FDA approval of MDMA-assisted therapy for PTSD closer than ever to becoming a reality, and the recent rescheduling of both MDMA and psilocybin by the Australian Therapeutic Goods Administration for medical use, Optimi felt it was crucial to fill the void that exists in accessibility to high-quality MDMA drug candidates,” said Optimi CEO, Bill Ciprick.
On September 22, 2022, Optimi and ATMA Journey Centres announced their intent to proceed with a Phase I clinical trial application (CTA) using Optimi’s natural psilocybin extract and MDMA.
The goal of the trial is to support a pathway toward regulatory approval by establishing the safety and tolerability of both drug candidates on healthy patients.
Optimi Health products are still being investigated through a clinically validated development program for the purpose of applying for market authorization.
Optimi Health Corp. is a drug manufacturer and formulator licensed by Health Canada to produce and supply natural, GMP-grade psilocybin, synthetic psychedelic substances, and functional mushrooms that focus on the health and wellness markets.
Optimi Health Corp was up 4.17 per cent, trading at $0.25 at 13:47 ET.
