Australia is ramping up its Authorized Prescriber Scheme for psychedelic medicines, presenting a significant opportunity for Canadian biotechnology firms to supply it with safe and standardized good manufacturing practice-grade substances.
The Australian organization responsible for the regulation of therapeutic goods including drugs and medical devices, the Therapeutic Goods Administration (TGA), last year changed the classification of psilocybin and MDMA within the country’s Poisons Scheme to allow for them to be prescribed by authorized psychiatrists.
For this purpose, they are considered Schedule 8 Controlled Drugs but for all other purposes remain Schedule 9 Prohibited Substances.
Since July 1, 2023, specially authorized psychiatrists have been able to prescribe psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder.
Earlier this month, the co-founder of outpatient psychiatrist-led mental health organization Monarch Metal Health Group Ted Cassidy became the first doctor to prescribe MDMA psychedelic-assisted therapy for PTSD to a female patient under the Authorized Prescriber Scheme.
“I am proud that Australia has taken world leadership in translating psychedelic research into clinical reality,” he wrote in a post on LinkedIn.
Several Canadian psychedelics-focused biotech companies have already overcome the significant regulatory and logistical challenges surrounding the export of controlled substances like MDMA and psilocybin into Australia, paving the way for them to supply the nation’s scheme as more patients are prescribed these drugs to treat mental health conditions.
British Columbia-based Filament Health Corp (NEO:FH, OTCQB:FLHLF) earlier this month completed its first export of its botanical psilocybin drug candidate PEX010 to its partner Reset Mind Sciences located in Perth, Western Australia.
The company is a longtime supplier of Canada’s Special Access Program, a framework which allows healthcare professionals to request access to non-marketed drugs not available for sale such as psilocybin or MDMA for patients with a serious or life-threatening condition on a case-by-case basis.
While Filament’s drug product will be used by Reset for research purposes, the export, which is believed to be the first export involving botanical psilocybin into Australia, demonstrated the company’s regulatory capabilities.
Reset is advancing a GMP licence application to manufacture psilocybin products from botanically sourced psilocybin for human consumption as it awaits the publication of the TGA’s order governing psilocybin production in Australia, Filament highlighted.
“We are closely monitoring the Authorized Prescriber Scheme, and we commend the TGA for including botanical products in their draft guidance for the products,” a Filament Health spokesperson told Proactive.
Another Canadian firm working to supply Australia’s scheme is PharmAla Biotech (CSE:MDMA), a company focused on the manufacturing of novel MDXX class molecules including MDMA.
In November, PharmAla announced it had completed its first shipment of MDMA and psilocybin to Cortexa, its Australian joint venture with Vitura Health Limited.
This marked the first time that these drugs have been brought into Australia specifically to be used under the Authorized Prescriber Scheme rather than for clinical trial purposes, the company said.
Drug manufacturer Optimi Health Corp (CSE:OPTI, OTCQB:OPTHF) through a partnership with Mind Medicine Australia (MMA), an Australian mental health charity and provider of psychedelic-assisted therapy training, is positioned to be another supplier of the scheme.
Through this partnership, announced in March 2023, Optimi is contracted to supply its MDMA formulation PTI-MHCL and GMP psilocybin capsules to MMA on an ongoing basis.
In a November 2023 shareholder update, Optimi said it continues to collaborate with MMA to navigate intricacies related to the scheme.
It noted that once a psychiatrist has received approval from the TGA to become an authorized prescriber it can apply for an import permit for Optimi’s drug candidates. The approval of such a permit can take up to 45 days after which Optimi will initiate the shipment of the drugs to Australia.