Australia to allow prescription of MDMA and psilocybin

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

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

“These are the only conditions for which there is currently sufficient evidence of potential benefits in some patients,” the agency said.

The amendment follows substance reclassification requests made to the TGA, extensive public consultation and an expert panel report.

This change means that MDMA and psilocybin, which were previously Schedule 9 prohibited 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, except in provinces where they are decriminalized.

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

Prescribing psychiatrists will need to be licensed under the TGA’s Authorized Prescriber Program and receive approval from a Human Research Ethics Board.

Although there are currently no approved products containing psilocybin or MDMA, psychiatrists will be able to access and legally supply specified “unapproved” medication containing these substances.

Stephen Bright, the charity’s director Psychedelic Research in Science and Medicinetold the 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 slim. There are no products available, and apart from me and a handful of colleagues, there is no one trained to provide the treatment. We are waiting for a bit more information, to get an idea of ​​what this looks like in practice,” he added.

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

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

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