Optimi Health Completes First Production of Novel MDMA Drug Candidate OPTI-MHCL

 Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF | FRA: 8BN), an end-to-end Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply natural, GMP-grade psilocybin, synthetic psychedelic substances, and high-quality functional mushrooms, is pleased to announce the completion of its proprietary preclinical MDMA drug candidate OPTI-MHCL 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.

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. 

“OPTI-MHCL is a true end-to-end product available on demand. It was conceptualized and produced by a single team of dedicated scientific personnel operating entirely under one roof while being subject to the highest possible standards of quality. With patients and providers reasonably anticipating access to these modalities, an inherent level of trust in the safety and purity of the product being administered is essential. The level of accountability, transparency, and oversight involved in the proprietary development of OPTI-MHCL gives us full confidence that no other such GMP product currently exists on the Canadian or global markets,” Ciprick added.

On September 22, 2022, Optimi and ATMA Journey Centers 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 towards 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. Though the Company has conducted rigorous internal analysis, the safety and efficacy of our products are still being formally established.

Optimi Health Corp. is an end-to-end Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply natural, GMP-grade psilocybin, synthetic psychedelic substances, and high-quality functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi’s products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.