For the first time since Australia rescheduled MDMA and psilocybin, a shipment of the compounds has been made to the country to be used under the country’s Authorized Prescriber Scheme rather than for clinical trial research.
In February 2023, Australia made changes to its drug scheduling to enable the prescription of MDMA and psilocybin for patients – making it the first country in the world to regulate psilocybin and MDMA as mental health treatments.
Australia’s Therapeutic Goods Administration (TGA) is now permitting for the prescription of MDMA for post-traumatic stress disorder (PTSD), and of psilocybin for treatment-resistant depression under its Authorized Prescribers Scheme.
This historic shipment of the compounds was made by PharmAla Biotech Holdings to Cortexa, its 50:50 Australian Joint Venture with Vitura Health Limited. The company has stated that the shipment was completed in several parts, includes both psilocybin and MDMA, and contains a both API and finished drug product capsules.
CEO of PharmAla Biotech, Nick Kadysh, stated: “As the Australian market continues to develop we are seeing significant interest among both clinical trial practitioners and clinic operators who are racing to establish themselves as the most capable actors in the provision of treatments to patients.
“However, when it comes to the provision of pharmaceutical grade medicines which underpin those treatments, I don’t believe there is competition: Cortexa stands as the industry leader in the import, sale and distribution of psilocybin and MDMA for medical purposes.”
PharmAla has emphasised that the provision of the compounds for Cortexa’s commercial use and the transfer of relevant intellectual property to Cortexa “allows for Cortexa to subsequently rely on domestic manufacturing within Australia, rather than imports” enabling lower cost-of-goods and a shorter time to market for the products.
CEO of Vitura Health, Rodney Cocks, stated: “As PharmAla’s JV partner in Cortexa, we at Vitura Health are proud to continue to lead the industry in the provision of both of GMP-grade Psilocybin and MDMA, which will be used in treating patients as soon as possible. However, as almost anyone involved in this industry can attest, the import of these materials presents significant logistical and regulatory challenges.
“That’s why I’m pleased that Cortexa, as demand grows, can embark upon its next logical step, scaling domestic manufacture of GMP grade psilocybin and MDMA to fulfill local demand without the difficulty, cost, and lag of foreign-made materials”
