Two psychedelics approved for therapy

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Australia will allow psychedelic drugs to be used in the treatment of specific health conditions from July 1.

On Friday the Therapeutic Goods Administration (TGA) announced changes to the classification of psilocybin, a naturally occurring psychedelic compound, and MDMA, allowing the prescription of medicines containing these compounds.

From July 1, specifically authorised psychiatrists will be permitted to prescribe MDMA (3,4-methylenedioxy-methamphetamine) for the treatment of post-traumatic stress disorder.

Psilocybin will be allowed to be prescribed for treatment-resistant depression.

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

“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses.”

Under the reclassification, both compounds will be listed as Schedule 8 medicines for this use, while other uses will remain under Schedule 9, which restricts their supply to clinical trials.

The TGA said there is currently no approved products containing these compounds, but the reclassification will allow authorised psychiatrists to access “unapproved” medicines.

The announcement comes after the TGA referred a decision to down-schedule MDMA and psilocybin to an independent expert panel in 2021.

In October the same year, the panel found, following a meta-analyses of existing studies, both compounds “may show promise” when administered in a supervised setting with intensive professional support.

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