Several Canadian biotechnology companies are poised to make a killing in the Australian market after the county’s Therapeutic Goods Administration (TGA) allowed psychiatrists to prescribe MDMA and psilocybin in 2023. The TGA regulates therapeutic goods such as medical devices and prescription drugs in Australia. It approved the prescription of psilocybin, the main psychoactive agent in magic mushrooms, and MDMA by changing their classification in Australia’s Poisons Scheme.
The TGA’s changes to the Poisons Scheme mean that the two psychedelics are considered Schedule 8 Controlled Drugs for specific uses. However, psilocybin and MDMA will remain in Schedule 9 (Prohibited Substances), which largely restricts their supply to clinical trials. That said, the approval means that Australian psychiatrists with special authorization can now prescribe MDMA to treat post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression. With the nation preparing its Authorized Prescriber Scheme for psychedelics-based medicines, the nascent psychedelic market is completely ripe for the taking.
Biotechnology companies from Canada are set to reap big from Australia’s psychedelic segment by supplying the industry with standardized and safe good manufacturing practice-grade substances. The Authorized Prescriber Scheme is still in its infancy and recently reached a major milestone after Monarch Mental Health Group cofounder Ted Cassidy became the first physician to prescribe MDMA-assisted therapy to treat a female patient with PTSD.
Several Canada-based biotech companies with a focus on psychedelics have already completed the logistical and regulatory steps required to facilitate the export of controlled substances such as MDMA and psilocybin to Australia. Now that they have overcome the significant legal and logistical challenges involved, these Canadian companies are ready to begin shipping MDMA and psilocybin to Australia.
British Columbia-based Filament Health Corp. recently made its first export of PEX010, a botanical psilocybin drug candidate, to Perth-based Reset Mind Sciences. Filament has plenty of experience supplying drugs to specialized programs such as the Authorized Prescriber Scheme. The British-Columbia-based biotech company supplied Canada’s Special Access Program with nonmarketed drugs that aren’t available for retail sale for patients with severe or life-threatening conditions for several years.
Reset Mind Sciences will use Filament’s product for research purposes. It is currently looking to secure a GMP license application to manufacture botanically sourced psilocybin products for human consumption.
Toronto-based PharmAla Biotech is also working to supply MDMA and psilocybin to Australia’s psychedelics space. In late 2023, the company announced the completion of its first psilocybin and MDMA shipment to Australian partner Vitura Health Limited. In addition, Optimi Health Corp from Garibaldi Highlands, British Columbia, has partnered with mental-health charity and psychedelic-assisted therapy training provider Mind Medicine Australia to supply psychedelics under the Authorized Prescriber Scheme.
The opening of more international markets is likely to provide impetus to psychedelic drug developers such as Compass Pathways PLC (NASDAQ: CMPS) to speed up their R&D efforts in order to tap the growing market for drugs based on hallucinogens.
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