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Australian psychiatrists permitted to prescribe MDMA and psilocybin for mental illnesses

Feb 3, 2023
The Therapeutic Goods Administration (TGA), which regulates therapeutic goods in the country, announced the change earlier this week. The TGA will permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.
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Authorized psychiatrists in Australia will be able to prescribe MDMA and psilocybin, the active ingredient in magic mushrooms, beginning in July.

The Therapeutic Goods Administration (TGA), which regulates therapeutic goods in the country, announced the change earlier this week.

The TGA will permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.

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

The change means MDMA and psilocybin, previously schedule 9 prohibited substances, will now be considered schedule 8 controlled drugs when prescribed by a psychiatrist. In any other instance, such as recreational use, they will remain schedule 9 drugs.

“The decision acknowledges 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 approved under the TGA’s authorized prescriber scheme as well as receive approval by a human research ethics committee.

The amendment follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation and a report from an expert panel.

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

Stephen Bright, the director of the Psychedelic Research in Science and Medicine charity, told The Sydney Morning Herald that the announcement “was unexpected given that Australia is such a conservative country.”

“The details so far from the TGA are thin. There’s no products available, and aside from myself and a handful of colleagues, there’s no one trained to provide the treatment. We’re waiting for a bit more information, to get an idea of what this looks like in practice,” he added.

Earlier this week it was announced that Swinburne University of Technology, a public research university based in Melbourne, had signed a $5 million clinical trial research agreement with Woke Pharmaceuticals.

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 a placebo.

“Psychedelics could transform the landscape of treatments 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 psychedelics research.”

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