In an Australian-first pharmaceutical achievement, Vitura Health Limited (ASX:VIT) has announced it has enabled the psychedelic drug GMP Psilocybin – also known as magic mushrooms – to be supplied to a patient for therapeutic use outside of a clinical trial.
The milestone was achieved by Vitura through its joint venture Cortexa.
Australia is currently the only market in the world to allow GMP Psilocybin to be supplied for therapeutic use outside of clinical trials.
The landmark prescription means that Cortexa can now be defined as the first Australian company to manufacture, supply and deliver both GMP MDMA and Psilocybin for both clinical trials and prescriptions via the TGA (therapeutic goods administration)’s Authorised Prescriber Scheme.
Cortexa was established last May, when Vitura entered a 50:50 joint venture agreement with Canadian biotechnology firm PharmAla Biotech Holdings, which concentrates on the research, development, and manufacture of MDXX class molecules (including MDMA), with a view to supplying both this and psilocybin for prescription use in Australia.
Upon the joint venture’s establishment, the TGA shifted both of these medicines from Schedule 9 to Schedule 8 under the Authorised Prescriber Scheme.
This means that authorised psychiatrists could now prescribe MDMA for the treatment of post-traumatic stress disorder, and psilocybin for treatment resistant depression.
The rescheduling was a key first step for Cortexa in building its reputation in Australia’s psychedelic market, and it went on to create a network of relationships with research institutes, key opinion leaders and emerging clinicians, and supported psychiatrists for obtaining their authorised prescriber status.
Supply arrangements have been secured for both clinical trials and authorised prescribers’ use for 2024 and beyond.
VIT shares last traded at 15cps; up 3.45%.