Optimi Health launches psilocybin capsules in Australia

Executive Summary

• Optimi Health Corp. has commercially launched its natural psilocybin capsules in Australia for the treatment of treatment-resistant depression (TRD) under the Authorised Prescriber Scheme.
• The initial shipment consists of 1,000 capsules, each containing 5mg of standardized naturally derived psilocybin, manufactured in-house at Optimi’s GMP-licensed facility in British Columbia, Canada.
• This launch marks the second psychedelic finished drug product commercially available for prescription use in Australia, following the introduction of MDMA sales for PTSD in October 2024.

Key Details

• Product Specifications: The launched product is a 5mg natural psilocybin capsule.
• Manufacturing & Compliance:
  • Manufactured entirely in-house at Optimi’s GMP-licensed facility in British Columbia, Canada.
  • Process includes cultivation, extraction, formulation, and encapsulation under a Health Canada-issued drug establishment licence.
  • Product passed independent Certificate of Analysis (COA) testing confirming compliance with Australia’s Therapeutic Goods Administration (TGA) specifications.
  • Export clearance obtained from Health Canada, the TGA, and Australia's BICON Biosecurity Authority.
• Commercial Distribution:
  • Mind Medicine Australia serves as the authorized commercial partner.
  • Distribution and patient coordination are managed through a network of clinics and hospitals in Australia.
  • Patient-reported outcome data will be collected to support real-world evidence for psilocybin.
• Strategic Context:
  • This launch follows the successful introduction of MDMA sales in Australia for posttraumatic stress disorder (PTSD) in October 2024.
  • Optimi now has two psychedelic finished drug products commercially available under a government-sanctioned prescription framework in Australia.
  • Products are also accessible in Canada through the Special Access Program.

Notable Quotes

• Dane Stevens, CEO of Optimi: "Launching our five mg natural psilocybin finished drug product alongside our 40 mg and 60 mg MDMA capsules is an exciting milestone for Optimi. For the first time, both of our GMP psychedelic medicines are available through a regulated government program -- a major step forward in our mission to deliver scalable psychedelic treatments directly to clinics."
• Peter Hunt AM, Chair of Mind Medicine Australia: "This is a significant step for Australian patients suffering from TRD. Much of this initial shipment will be allocated across our network of clinics, underscoring the growing demand in the market today. We look forward to continuing our collaboration with Optimi to ensure broad, cost-effective access to patients throughout the country."