Vancouver, British Columbia–(Newsfile Corp. – June 25, 2024) – Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) (“Optimi” or the “Company”), a Health Canada-approved, GMP-compliant pharmaceutical drug manufacturer specializing in the controlled substances MDMA and botanical psilocybin, is pleased to announce that it has received the three necessary export permits from Health Canada to supply GMP MDMA and psilocybin capsules for use in patients participating in Australia’s Authorised Prescriber Scheme.
Beginning with 160 doses, this milestone marks Optimi’s commercial entry into Australia with its GMP psychedelic medicines for eligible patients suffering from PTSD and Treatment-Resistant Depression. Optimi’s MDMA and psilocybin capsules will be exported from the Company’s GMP-compliant production facility in Canada, using Optimi’s newly awarded Drug Establishment Licence (DEL).
After the Therapeutic Goods Administration (TGA) reclassified MDMA and psilocybin from Schedule 9 to Schedule 8 in 2023, Australia became the first country in the world to permit the regulated use of these substances under medical supervision in a therapeutic setting.
“Receiving the export permits from Health Canada is a great achievement for both the Optimi team and shareholders alike,” said JJ Wilson, Co-Founder and Chairman. “It underscores the Company’s commitment to advancing our global supply efforts to provide medical professionals, in Australia, with the tools they need to offer psychedelic-assisted therapies to those suffering with PTSD and Treatment-Resistant Depression.”
This initiative is crucial for collecting Real World Evidence (RWE) and Patient-Reported Outcomes (PROs), which will contribute meaningful data to the growing body of research supporting the therapeutic potential of Optimi’s GMP MDMA and psilocybin capsules.
Wilson added, “We are eager to understand patient-reported outcomes using Optimi’s MDMA and psilocybin capsules, and we believe this is a critical pathway to provide the evidence needed to build confidence in psychedelic-assisted therapy. The TGA has demonstrated its leadership through the reclassification of these medicines, and we are grateful to have the infrastructure in place to supply this groundbreaking program.”
Under the Authorised Prescriber Scheme, the capsules will be imported by Mind Medicine Australia and further distributed to licensed pharmacies around the country. These pharmacies ensure a secure and efficient supply chain, enabling medical professionals to access these medicines seamlessly on behalf of patients.
Mind Medicine Australia, a partner with Optimi since February 2023, achieved a world-first last year by successfully advocating for the reclassification of MDMA for the treatment of PTSD and psilocybin for Treatment-Resistant Depression (TRD). As a result, these medicines are now available to Authorised Prescribers in Australia, paving the way for groundbreaking therapeutic options this year.
Additionally, the Company is set to launch its Prescriber Portal in the coming days for Australian psychiatrists seeking more information about Optimi’s drug candidates and manufacturing capabilities.
For psychiatrists looking for more information about Optimi and the Authorised Prescriber Scheme, please visit www.optimihealth.ca.
On Behalf of the Board of Directors,
Dane Stevens, CMO & Director
Telephone: (778) 761-4551
For media inquiries, please contact:
Andrea Mestrovic
andrea@weareverypolite.com
For investor inquiries, please contact:
Michael Kydd
investors@optimihealth.ca
902.880.6121
www.optimihealth.ca
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN)
Optimi is the only psychedelics pharmaceutical manufacturer in Canada with both a Controlled Drugs and Substances Dealer’s Licence and a Drug Establishment Licence (DEL). Specializing in controlled substances such as botanical psilocybin and MDMA, Optimi is dedicated to supplying safe, top-tier GMP-grade products and API to researchers, drug developers, and authorized patients in markets across the world.
Our leadership is reinforced by our state-of-the-art, GMP-compliant cultivation, formulation, and analytical facilities, purpose-built to develop proprietary formulations that meet the highest standards of quality and responsible sourcing. Located in Princeton, British Columbia, our two facilities total 20,000 square feet where all products are grown and manufactured in-house under strict GACP and GMP conditions, ensuring unparalleled quality and reliability. Optimi is committed to being the most trusted and compassionate supplier of safe drug candidates worldwide.