Mr. Dane Stevens reports
OPTIMI HEALTH REPORTS EARLY CLINICAL ROLLOUT OF NATURAL PSILOCYBIN CAPSULES FOR TREATMENT-RESISTANT DEPRESSION IN AUSTRALIA
Patients diagnosed with treatment-resistant depression have been treated in Australia using Optimi Health Corp.'s naturally derived five-milligram psilocybin capsules under the authorized prescriber scheme.
The clinical administration follows the company's first psilocybin shipment of 2026 and represents the early rollout of Optimi's finished drug product across authorized clinics operating within Australia's nationally regulated access framework. Product was dispensed through Optimi's licensed Australian pharmacy partner pursuant to approved import permits prior to clinical administration. Treatments were administered by authorized prescribers in accordance with Australian regulatory requirements.
This milestone occurs approximately six months following Optimi's initial commercial launch of psilocybin supply into Australia and reflects early-stage clinical adoption within the regulated access pathway. Prior to this, the company completed multiple MDMA shipments for supply under Australia's authorized prescriber scheme. Optimi is supplying both psilocybin for TRD and MDMA for posttraumatic stress disorder into Australia's nationally regulated medical framework.
Both products are produced at Optimi's accredited facility in Canada and comply with the Therapeutic Goods Administration quality guidelines, including TGO 112 and TGO 113, where applicable.
"We are seeing the authorized prescriber pathway function as intended -- enabling regulated access for eligible patients under appropriate clinical oversight," said Ilan Hayman of Mind Medicine Australia. "The early administration of psilocybin-assisted therapy under this framework reflects careful implementation by clinicians and the continued maturation of Australia's regulated access model."
Treatment data and patient-reported outcomes are being captured through Australia's national registry in partnership with Australian National University. Psilocybin-assisted therapy in Australia is prescribed through authorized programs supported by Mind Medicine Australia.
Clinicians, hospital networks and authorised programs operating under the authoriZed prescriber scheme may seek information regarding access through Mind Medicine Australia.
About Optimi Health Corp.
Optimi Health is a leading producer of prescribed psychedelic treatments for mental health therapies. As a Health Canada-licensed, good-manufacturing-practice-compliant pharmaceutical manufacturer producing validated MDMA and botanical psilocybin products from two 10,000-square-foot facilities in British Columbia, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia through the authorized prescriber scheme and accessible in Canada through the special access program.
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