In what it claimed as an “Australian first”, Vitura Health has supplied GMP psilocybin for therapeutic use by a patient outside of a clinical trial under the Authorised Prescriber (AP) scheme.
Last year, Vitura announced Cortexa, 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.
Vitura told the ASX 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).
Following the rescheduling of the medicines from S9 to S8, Vitura said Cortexa has built relationships with research institutes, opinion leaders and emerging clinicians, and supported psychiatrists in obtaining AP status.
It added supply arrangements have been secured for use in both clinical trials and by APs in 2024 and beyond.
