Cortexa, a joint venture backed by Vitura Health, has begun batch manufacturing GMP MDMA 40mg capsules intended to support clinical trials and supply under the Authorised Prescriber (AP) scheme.
Vitura described the shift to domestic manufacturing as a "significant milestone" for Cortexa, saying it advances the company's goal of building a dependable local supply chain.
"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, through which it holds exclusive rights to purchase and distribute the Canada-based research and development firm's GMP-manufactured psychedelic products across Australia.
Cortexa has also signed an exclusive agreement 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."
Together with the intellectual property and manufacturing know-how available through PharmAla Biotech, Vitura said the Optima arrangement will "enable onshore manufacture and a secure, domestic source of medication independent of the international supply chain."
Cortexa is set to launch a medical education program in the near term, aimed at raising awareness of psychedelic-assisted therapy within the wider adult psychiatry community, while continuing to engage with peak bodies and key customers.
Last month, Vitura said Cortexa had achieved "an Australian first" after it supplied GMP psilocybin for therapeutic use by a patient outside of a clinical trial through the AP scheme.
Separately, Emyria has announced that a second psychiatrist within its network has received AP approval from the TGA to prescribe MDMA.
Earlier this week, the ASX-listed company entered a binding research agreement with charity Reach Wellness to assess the effectiveness of its MDMA-assisted therapy program for first responders living with post-traumatic stress disorder (PTSD).
From July 1, 2023, the TGA has permitted approved psychiatrists to prescribe psilocybin and MDMA for treatment-resistant depression and PTSD.
