Australia to allow MDMA and psilocybin prescriptions

In Australia, licensed psychiatrists will be able to prescribe MDMA and psilocybin, the active ingredient in magic mushrooms, from July 2023.

The Therapeutic Goods Administration (TGA), which regulates medicines in Australia, will authorize the prescription of MDMA for the treatment of post-traumatic stress disorder and psilocybin for depression treatment-resistant.

«These are the only conditions for which there is currently sufficient evidence of potential benefit in certain patients,» the agency said.

The amendment follows requests for reclassification of substances to the TGA, extensive public consultation and the report of a panel of experts.

This change means that MDMA and psilocybin, previously prohibited Schedule 9 substances, will now be considered Schedule 8 controlled substances when prescribed by a psychiatrist. In all other cases, such as recreational use, they will remain Schedule 9 drugs, with the following exceptions provinces where they are decriminalized.

«This decision recognizes the current lack of options for patients with specific treatment-resistant mental illnesses,» said the TGA. «It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.»

Prescribing psychiatrists will need to be accredited under the TGA's authorized prescriber program, and receive approval from a human research ethics committee.

Although there are currently no approved products containing psilocybin or MDMA, psychiatrists will be able to legally access and supply a specified «unapproved» drug containing these substances.

Stephen Bright, director of the charity Psychedelic Research in Science and Medicine, said at Sydney Morning Herald that the announcement «was unexpected given that Australia is such a conservative country».

«The details provided so far by the TGA are thin. There are no products available, and apart from myself and a handful of colleagues, there's no one trained to provide the treatment. We're waiting for a little more information, to get an idea of what it looks like in practice,» he added.

Early last week, it was announced that the Swinburne University of Technology, a public research university based in Melbourne, had signed a research agreement on psychedelics. According to Swinburne, the trial will be the largest in Australia to study psychedelic mushrooms and treatment-resistant depression. Around 160 patients will take part in a randomized controlled trial of psilocybin-assisted psychotherapy versus placebo.

«Psychedelics could transform the treatment landscape for many psychiatric disorders, including major depression,» said Professor Susan Rossell. «We have the opportunity to make a substantial difference and for Australia to lead the way in psychedelic research.».