Vitura Health has supplied GMP psilocybin for therapeutic use to a patient outside of a clinical trial through the Authorised Prescriber (AP) scheme, which the company described as an "Australian first".
Last year, Vitura announced Cortexa, a 50:50 joint venture with PharmAla Biotech that grants it exclusive rights to purchase and distribute the Canada-based research and development firm's GMP-manufactured psychedelic products across Australia.
In an ASX announcement, Vitura said Cortexa is "the first Australian company able to immediately manufacture, supply and deliver GMP MDMA and psilocybin for both clinical trials and prescriptions via the TGA's Authorised Prescriber scheme".
Since July last year, psychiatrists approved under the scheme have been permitted to prescribe MDMA and psilocybin for treatment-resistant depression and post-traumatic stress disorder (PTSD).
After both medicines were rescheduled from S9 to S8, Vitura said Cortexa has developed relationships with research institutes, opinion leaders and emerging clinicians, and assisted psychiatrists in securing AP status.
The company also said supply arrangements have been put in place for use in both clinical trials and by APs in 2024 and beyond.
