Vitura Health has landed bulk and patient-ready Good Manufacturing Practice (GMP) MDMA in Australia as it gears up for the first patients to be treated under the TGA’s new Authorised Prescriber scheme.
The scheme, unveiled in February and effective from July 1, allows approved psychiatrists to prescribe MDMA and psilocybin for treatment-resistant depression and post-traumatic stress disorder (PTSD).
Vitura said the first tranche of psychiatrists are expected to be approved by the regulator in the coming weeks, enabling patients to be treated outside of clinical trials by December.
It formed a joint venture called Cortexa with PharmAla Biotech in May giving it exclusive rights to buy and distribute the Canadian firm’s GMP-manufactured psychedelic products in Australia. Cortexa also has access to PharmAla’s intellectual property giving it the option of manufacturing onshore as demand grows.
Vitura said the bulk MDMA Active Pharmaceutical Ingredient (API) will be batch manufactured into finished dosage forms to GMP standards enabling Cortexa to “ensure reliable local supply to meet growing clinical and research demands”.
GMP MDMA capsules have also been imported from PharmAla and are ready for patient prescriptions and clinical trials.
Vitura added the majority of the shipment would satisfy demand under existing supply agreements including clinical trials. Psilocybin bulk GMP API is also in the process of being transported to Australia.
CEO Rodney Cocks said: “We are extremely proud to have landed MDMA product in bulk and patient-ready capsule form into Australia – for clinical and research prescription.
“By the end of November 2023, we also expect to have landed bulk psilocybin GMP product also for clinical and research prescription. This paves the way for the first expected clinical patients via the TGA’s Authorised Prescriber Scheme access pathway in December 2023.
“As a veteran myself, I am delighted that Cortexa now has MDMA GMP product in Australia that can be prescribed via the Authorised Prescriber pathway… to those suffering PTSD who are some of the most vulnerable in our community, including veterans and first responders.
“We look forward to supporting those who have given so much to Australia.”