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.”
How to Access Optimi’s MDMA Capsules
Entities interested in accessing Optimi’s MDMA capsules can contact:
Australia: Mind Medicine Australia
Global Inquiries: sales@optimihealth.ca
About Optimi Health
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.
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On Behalf of the Board of Directors
JJ Wilson
Chairman, Optimi Health Corp.
For more information, please contact the Company at:
Telephone: (778) 761-4551
Email: investors@optimihealth.ca
Website: www.optimihealth.ca