Vitura Health has received both bulk and patient-ready Good Manufacturing Practice (GMP) MDMA in Australia as it prepares to treat the first patients under the TGA's new Authorised Prescriber scheme.
The scheme, announced in February and set to take effect from July 1, permits approved psychiatrists to prescribe MDMA and psilocybin for treatment-resistant depression and post-traumatic stress disorder (PTSD).
Vitura said the first group of psychiatrists is expected to receive regulatory approval within the coming weeks, which would allow patients to be treated outside of clinical trials by December.
The company established a joint venture called Cortexa with PharmAla Biotech in May, securing exclusive rights to purchase and distribute the Canadian company's GMP-manufactured psychedelic products across Australia. Cortexa also holds access to PharmAla's intellectual property, giving it the option to manufacture domestically as demand increases.
Vitura said the bulk MDMA Active Pharmaceutical Ingredient (API) will be batch-manufactured into finished dosage forms to GMP standards, allowing Cortexa to "ensure reliable local supply to meet growing clinical and research demands."
GMP MDMA capsules have also been imported from PharmAla and are available for patient prescriptions and clinical trials.
Vitura noted that the majority of the shipment will fulfil demand under existing supply agreements, including those tied to clinical trials. Bulk psilocybin GMP API is currently being transported to Australia as well.
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."
