Australian medicinal cannabis company Vitura Health Limited has released an update on its Cortexa Joint Venture with PharmAla Biotech after landing bulk GMP Active Pharmaceutical Ingredient (API) for MDMA (3,4-Methylenedioxy-methamphetamine) in Australia.
This bulk API will be used for batch manufacturing into finished dosage forms while adhering to GMP (Good Manufacturing Practice) standards, Vitura said in a press release.
According to the ASX-listed company, the move is aimed at ensuring a consistent and secure local supply to meet the growing demand in clinical research and treatment.
Simultaneously, the first batch of GMP MDMA capsules has been imported from Cortexa’s joint venture partner, PharmAla Biotech, and is now ready to be prescribed for patients and utilised in clinical trials.
A significant portion of this shipment has been allocated to fulfil the requirements of existing supply agreements, including collaborations with leading university clinical trials.
Cortexa is also in the process of transporting bulk GMP Active Pharmaceutical Ingredient for psilocybin, a naturally occurring psychedelic compound found in magic mushrooms.
Similar to the case of MDMA, there is a growing interest in the clinical and research use of psilocybin, and Cortexa is actively working on ensuring a GMP-standard supply to meet this demand.
The update highlighted that the first patients are expected to be treated under the TGA’s (Therapeutic Goods Administration) Authorised Prescriber Scheme through approved psychiatrists in December 2023.
Furthermore, the announcement revealed that as the demand for GMP MDMA and psilocybin continues to rise, Cortexa has the option to explore onshore manufacturing in Australia through GMP contract manufacturers.
This strategic move allows Cortexa to avoid the challenges and delays associated with importation activities, ultimately securing the future domestic supply for patients and clinical trial participants.
Rodney Cocks, CEO and executive director of Vitura, expressed pride in these accomplishments and emphasised their commitment to providing critical treatments to those in need, especially individuals suffering from PTSD.
“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,” Cocks remarked.
He noted the significance of offering access to GMP MDMA through the Authorised Prescriber pathway, particularly for vulnerable populations such as veterans and first responders.
“We will continue to update our shareholders on the ongoing success of Cortexa, as a leading supplier of GMP MDMA and psilocybin for clinical and research prescriptions in the Australian market,” Cocks concluded.
