Third commercial shipment targets treatment-resistant depression
Optimi Health has completed an export of 1,000 capsules of 5mg psilocybin to Australia, where doctors prescribe the drug for treatment-resistant depression. This is the company’s third commercial shipment since it launched the finished product in September 2025.
Optimi is based in Vancouver, British Columbia, and trades on Nasdaq as OPTH, on the CSE as OPTI and on the FSE as 8BN0. It manufactures regulated psychedelic medicines, including psilocybin and MDMA.
Treatment-resistant depression means major depression that has not improved after multiple standard antidepressant treatments. That leaves a significant unmet medical need for many patients.
On July 1, 2023, Australia became the first country to recognise psilocybin as a medicine by moving it from a prohibited substance to a controlled medicine for treatment-resistant depression. On the same day, Australia also rescheduled MDMA for post-traumatic stress disorder.
Authorised Prescriber Scheme
In Australia, patients receive psilocybin under the Therapeutic Goods Administration’s Authorised Prescriber Scheme. Access widened again after updates expanded therapist eligibility and treatment settings, changes Optimi detailed in a May 29, 2026 release.
Public and private payers reimburse Optimi’s psilocybin in Australia. Those payers include the Department of Veterans’ Affairs, the National Disability Insurance Scheme, WorkCover and Medibank.
Meanwhile, more than 750 clinicians have trained to deliver the therapy. After more than two years of regulated commercial use, Optimi reported no serious adverse events under the scheme.
Chief executive and co-founder Dane Stevens said: “We are proud to be among the few Nasdaq-listed companies commercially supplying psilocybin to patients with treatment-resistant depression outside of clinical trials.”
Optimi also reported expanding reimbursement coverage from both private and public insurers as prescribing grows in real-world care.
At Optimi’s wholly owned GMP facility in Princeton, British Columbia, staff produced the capsules start to finish in-house. The site operates under a Health Canada Drug Establishment Licence, and Health Canada authorised the export.
Stevens said: “We believe Australia is providing an early model for how naturally derived psilocybin can be safely prescribed for TRD in real-world practice, and we are not aware of any serious adverse events reported since inception based on data collected through December 31, 2025.”
