Over 4,000 GMP Capsules Ready to Support PTSD Treatment in Australia, Israel, and Canada
Vancouver, British Columbia--(Newsfile Corp. - January 29, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce and supply natural, GMP-grade psilocybin and MDMA, has completed its largest production batch of MDMA to date-over 4,000 GMP capsules, enough to treat more than 1,000 patients.
As part of its commitment to ensuring long-term product stability and quality, Optimi has also completed one year of stability data on previously manufactured MDMA capsules, validating a one-year shelf life and extending the usability of its existing inventory for clinical and therapeutic applications. Additionally, the company has initiated a two-year stability program to further validate the long-term quality and reliability of its MDMA capsules.
With a growing number of authorized physicians prescribing Optimi's MDMA for PTSD in Australia, increasing demand for Special Access Program (SAP) requests in Canada, and a key Phase 2 clinical trial initiative for PTSD in Israel, Optimi is one of the few companies able to both manufacture its psychedelic drugs in-house and export cost-effective, GMP-grade MDMA capsules globally.
Highlights
Largest batch of MDMA capsules manufactured to date Optimi has produced over 4,000 GMP capsules of MDMA, enough to treat more than 1,000 patients globally, reinforcing its commitment to expanding access to psychedelic-assisted therapy.
One-year stability data extends current inventory Stability testing on previously manufactured 40 mg and 60 mg MDMA capsules confirms a one-year shelf life, ensuring continued availability for clinical and therapeutic applications.
Two-year stability program launched Optimi has initiated a two-year stability program to further validate the long-term quality and shelf life of its MDMA capsules.
Ongoing production for SAP, clinical trials, and regulated markets Optimi is running additional GMP production of both 40 mg and 60 mg MDMA capsules in the coming weeks to support:
A Phase 2 clinical trial initiative for PTSD in Israel
Special Access Program (SAP) requests in Canada
Fulfilling purchase orders for Australian patients prescribed Optimi's MDMA for PTSD
"What we find most rewarding is that a portion of this latest batch will be directly used to treat patients in 2025 in Australia, where a growing number of authorized doctors are prescribing Optimi's MDMA for PTSD under the Authorized Prescriber Scheme," said Dane Stevens, CEO of Optimi Health.
"Additionally, our customer feedback is that our MDMA offering is often more cost-effective than other limited options in the market, making it an attractive solution for both patients and healthcare providers. We are excited to be producing affordable and stable inventory in-house under our Drug Establishment Licence. Combined with our capacity to store up to $50 million (CAD) worth of scheduled substances in our secure vault, Optimi is uniquely positioned to meet increased demand efficiently and reliably."
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, GMP-grade psilocybin and MDMA for clinical research and therapeutic applications. Dedicated to the scalable production of the highest quality natural products, Optimi supports the global psychedelic industry with its state-of-the-art facilities and unparalleled commitment to safety and efficacy. By working closely with healthcare professionals, clinical researchers, and regulatory bodies, Optimi is delivering innovative solutions for mental health care and beyond.
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"), including statements pertaining to the study, the results of such study, the benefits of using psilocybin and the potential for follow on studies. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. 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. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. 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. Such risk factors include but are not limited to those factors which are discussed in the Company's long form prospectus dated February 12, 2021, a copy of which is available on SEDAR+ at www.sedarplus.com. Except as expressly required by applicable law, 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 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.
