Psychedelics, MDMA approved by TGA for mental health treatment

From July 1, 2023, people with post-traumatic stress disorder and depression will be able to benefit from the drugs, the Therapeutic Goods Administration (TGA) said on Friday.

The approval is for medicines containing psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine).

MDMA (also known as ecstasy) will be allowed for the treatment of post-traumatic stress disorder, and psilocybin (found in magic mushrooms) for treatment-resistant depression. These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients, the TGA said.

Only authorised psychiatrists will be able to prescribe these new treatments.

"The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses," the TGA said.

Edith Cowan University senior lecturer Dr Stephen Bright said recognising illegal drugs like MDMA and psilocybin have medical utility is an important step in drug policy reform.

"The safe provision of these treatments requires extensive training, which is why they have been limited to clinical research in Australia to date," he said.

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Cognitive neuropsychologist Professor Susan Rossell has a "significant degree of caution" about the approval.

"These treatments are not well established at all for a sufficient level of broad-scale implementation. Substantial further research needs to be done," she said.

The "safe re-medicalisation of certain historically illicit drugs" was welcomed by Australian National University emergency medicine clinical senior lecturer Associate Professor David Caldicott.

"[This] is a very welcome step away from what has been decades of demonisation," he said.

"In addition to a clear and evolving therapeutic benefit, it also offers the chance to catch up on the decades of lost opportunity in delving into the inner workings of the human mind, abandoned for so long as part of an ill-conceived, ideological 'war on drugs'."

The TGA said tight controls will be in place to protect patients during psychedelic-assisted psychotherapy.

For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (controlled drugs) medicines in the Poisons Standard.

For all other uses, they will remain in Schedule 9 (prohibited substances) which largely restricts their supply to clinical trials.