Vitura Health in JV To Supply First Psilocybin To Patients Under TGA Scheme

Vitura Health Ltd (ASX: VIT) and its joint venture partner PharmAla Biotech Holdings Inc have delivered an Australian first with the supply of GMP Psilocybin for therapeutic use outside of a clinical trial.

The supply was completed under the Therapeutic Goods Administration’s (TGA) Authorised Prescriber Scheme.

The 50:50 joint venture is with the Canadian-based PharmAla Biotech Holdings Inc. (CSE: MDMA).

The JV is building a pathway in the Australian psychedelic market.

PharmAla is focused on the research, development, and manufacture of MDXX class molecules, including MDMA.

Suppliers need to have appropriate licenses in place to supply both MDMA and Psilocybin for prescription use in Australia.

From 1 July 2023, specific psychedelics can be prescribed by approved authorised psychiatrists for the treatment of certain mental health conditions.

This includes treatments for post-traumatic stress disorder, MDMA, and for treatment-resistant depression, Psilocybin.

The JV aims to be the leading supplier of psychedelics, GMP MDMA, and GMP psilocybin, for research and therapeutic use in Australia.

Australia is currently the only market in the world to permit GMP Psilocybin for therapeutic use outside of clinical trials.

Therapeutics Goods Administration makes history

Recently, the TGA permitted the prescribing of specific psychedelics for the treatment of post-traumatic stress disorder and treatment-resistant depression.

These were under strict conditions and licensing approvals.

Changes made by the TGA represent a milestone for Australia’s nascent Psilocybin industry.

It gives hope to individuals seeking treatment for their mental health conditions and opens opportunities for further research and development of psychedelic medicines.

Vitura and its partner will be one of the only companies in the world able to supply the approved psychedelics ready for patient use.


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