Vitura Health joint venture Cortexa has started batch manufacturing GMP MDMA 40mg capsules to support clinical trials and use under the Authorised Prescriber (AP) scheme.
Vitura said domestic manufacturing represents a “significant milestone” for Cortexa and sees it executing its plan to develop a reliable local supply.
“This advantage will free local clinicians and researchers from the costly and time-consuming burden of importation and provides seamless access to medication,” the company told the ASX.
Cortexa is a 50:50 joint venture with PharmAla Biotech under which it has exclusive rights to buy and distribute the Canada-based research and development firm’s GMP-manufactured psychedelic products in Australia.
It has also entered an exclusive deal with Perth-based contract manufacturer Optima Ovest which Vitura said has “extensive experience in the manufacture of GMP, clinical-grade pharmaceutical products, with the capacity to scale operations in line with demand”.
Combined with Cortexa’s access to intellectual property and manufacturing experience via PharmAla Biotech, Vitura said the agreement with Optima will “enable onshore manufacture and a secure, domestic source of medication independent of the international supply chain”.
Cortexa will shortly commence a medical education program designed to increase awareness of psychedelic-assisted therapy among the broader adult psychiatry community and continue its engagement with peak bodies and key customers.
Last month, Vitura claimed “an Australian first” for Cortexa after it supplied GMP psilocybin for therapeutic use by a patient outside of a clinical trial under the AP scheme.
Meanwhile, Emyria has announced its second psychiatrist has received AP approval from the TGA for the prescribing of MDMA.
Earlier this week, the ASX-listed firm entered into a binding research agreement with charity Reach Wellness to evaluate the effectiveness of its MDMA-assisted therapy program for first responders with post-traumatic stress disorder (PTSD).
Since July 1, 2023, the TGA has allowed approved psychiatrists to prescribe psilocybin and MDMA for treatment-resistant depression and PTSD.
