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Australia’s TGA approves psychedelics to treat mental health conditions

Australia’s Therapeutic Goods Administration (TGA) has announced its approval of the use of psychedelics to treat certain mental health conditions. From 1 July 2023, medicines containing the psychedelic substances psilocybin (found in hallucinogenic fungi, also known as magic mushrooms) and MDMA can be prescribed by authorised psychiatrists to treat selected mental health conditions.
There is currently evidence that psychedelics have benefits for treating patients with post-traumatic stress disorder (PTSD) and depression, so it is only these two conditions for which the drugs can be prescribed. MDMA will be approved for PTSD while psilocybin will be approved for treatment-resistant depression.
This approval marks the TGA’s acknowledgement of the lack of treatments for some treatment-resistant mental health conditions, meaning the drugs will be able to be used therapeutically in a controlled medical setting.
Only psychiatrists approved under the TGA’s Authorised Prescriber Scheme will be able to prescribe these drugs, however there are currently no approved products containing the substances that have been assessed for safety, efficacy and quality, so psychiatrists will have access to ‘unapproved’ medicines to prescribe to their patients. For medical purposes the substances will be listed as Schedule 8 (controlled drugs) medicines in Australia’s Poisons Standard, but for all other uses they remain classified as Schedule 9(prohibitedsubstances).
Sarah-Catherine Rodan, PhD student at the University of Sydney, commented: “Safety and efficacy have been demonstrated in other indications such as nicotine/alcohol dependence, obsessive compulsive disorder and end-of-life distress. Further, depression is often co-occurring with these psychiatric disorders. The TGA clearly acknowledges that it does have therapeutic value and states that these substances are relatively safe when administered in a medically controlled environment.”
Professor Peter Duggan, senior principal research scientist at CSIRO believes this news is “really promising” for patients with these difficult-to-treat conditions, adding that it will “also be great encouragement for a number of local Australian companies whose goal is to commercialise psychedelic therapies based on psilocybin or MDMA.”