Health Canada Grants Three Export Permits to Optimi for Australia's Authorised Prescriber Scheme

Optimi Health Corp., a pharmaceutical drug manufacturer endorsed by Health Canada, has secured three essential export permits to send GMP MDMA and psilocybin capsules to Australia. This marks a significant step for Optimi as it ventures into the Australian market, aiming to aid patients diagnosed with PTSD and Treatment-Resistant Depression under Australia’s Authorised Prescriber Scheme. The company will ship an initial batch of 160 doses of these psychedelic medicines from its GMP-compliant facility in Canada.

Australia reclassified MDMA and psilocybin from Schedule 9 to Schedule 8 in 2023, becoming the first nation to permit the controlled use of these substances under professional medical supervision. This regulatory change by the Therapeutic Goods Administration (TGA) has opened new therapeutic possibilities for treating mental health conditions.

JJ Wilson, Co-Founder and Chairman of Optimi, emphasized the importance of acquiring the export permits, noting it as a significant achievement for the company and its stakeholders. This development not only highlights Optimi's commitment to expanding its global supply chain but also supports Australian medical professionals who are pioneering psychedelic-assisted therapies.

Wilson underscored the necessity of this initiative for gathering Real World Evidence (RWE) and Patient-Reported Outcomes (PROs). These data points are vital for expanding the research supporting the therapeutic use of MDMA and psilocybin. He believes that understanding patient-reported outcomes will be crucial in building confidence in these emerging treatments.

Under the Authorised Prescriber Scheme, Mind Medicine Australia will manage the import of the capsules and distribute them to licensed pharmacies nationwide. This ensures a secure and efficient supply chain, allowing medical professionals easy access to these treatments for their patients.

Mind Medicine Australia has been a key partner for Optimi since early 2023. Last year, the organization successfully advocated for the reclassification of MDMA for PTSD treatment and psilocybin for addressing Treatment-Resistant Depression. This advocacy has enabled the availability of these groundbreaking treatments to Authorized Prescribers in Australia.

In addition to this milestone, Optimi is preparing to launch its Prescriber Portal. This online resource will provide Australian psychiatrists with detailed information about the company’s drug candidates and manufacturing capabilities, offering a comprehensive guide to those interested in incorporating these innovative treatments into their practice.