Optimi Health completes first 2026 MDMA, psilocybin run

Executive Summary

• Optimi Health Corp. has completed its first production cycle of 2026 for MDMA and psilocybin capsules, intended for supply into Australia under the Authorised Prescriber Scheme.
• The production includes 1,000 MDMA capsules (60mg) and 1,000 psilocybin capsules (5mg), which have been released, approved for import, and are compliant with Good Manufacturing Practices (GMP).
• The company aims to expand access to these treatments for patients suffering from Posttraumatic Stress Disorder (PTSD) and Treatment-Resistant Depression (TRD) in Australia.

Key Details

• Production Volume: 1,000 MDMA capsules and 1,000 psilocybin capsules.
• Dosage Specifications: MDMA at 60-milligram dosage; Psilocybin at 5-milligram dosage (naturally derived).
• Regulatory Compliance: Final packaging, labelling, and batch release completed in accordance with Optimi's drug establishment licence issued by Health Canada.
• Quality Assurance: Products are GMP-compliant with Certificates of Analysis confirming conformance with applicable quality specifications.
• Import Status: Required Australian import permits have been received; the batch is released and approved for import.
• Target Market: Australian regulated healthcare system via the Authorised Prescriber Scheme.
• Therapeutic Indications: PTSD and Treatment-Resistant Depression (TRD).
• Market Context: Approximately 5-6% of Australians experience PTSD (1.3-1.5 million people); over 1.3 million affected by depressive disorders, with ~1/3 not responding to standard treatments.

Notable Quotes

• "This production run has been released and approved for import, allowing Optimi to continue supplying MDMA and psilocybin into Australia's regulated health care system," said Dane Stevens, chief executive officer of Optimi Health. "Completing this first production cycle of 2026 positions us to expand access across the country for patients suffering from PTSD and TRD."