Health Canada Issues Three Export Permits to Optimi to Supply Patients Under Australia's Authorised Prescriber Scheme
Optimi Health has received three export permits from Health Canada to supply MDMA and psilocybin capsules to Australian psychiatrists for treating PTSD and Treatment-Resistant Depression. With a shipment of 160 doses, this marks the company's first commercial entry into Australia. The capsules will be used under the Authorised Prescriber Scheme, facilitated by Mind Medicine Australia. This initiative aims to gather Real World Evidence and Patient-Reported Outcomes to support the therapeutic potential of these substances. Optimi's export is made possible by its GMP-compliant production facility and newly awarded Drug Establishment Licence.
- Received three export permits from Health Canada.
- Shipment of 160 doses of MDMA and psilocybin to Australia.
- First commercial entry into Australia for Optimi's psychedelic medicines.
- Aligned with Australia's reclassification of MDMA and psilocybin.
- Partnership with Mind Medicine Australia since February 2023.
- Potential to collect Real World Evidence and Patient-Reported Outcomes.
- None.
The Company will ship 160 doses of MDMA and psilocybin to Australian psychiatrists for the treatment of patients with PTSD and Treatment-Resistant Depression.
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,
OPTIMI HEALTH CORP.
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.
FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. Forward-looking statements made in this news release include the proposed use of the proceeds of the Offering. No assurance can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/214262
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