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Australia TGA Approves Psychedelics for Mental Health Treatment

— March 21, 2023

Australia’s drug regulatory agency approves the use of MDMA and psilocybin for treatment-resistant depression, PTSD.

MDMA and psilocybin are the two newest drugs that have been approved under Australia’s Therapeutic Goods Association (TGA), the country’s version of the U.S.’s Food and Drug Administration. The goal is to offer additional treatment options for treatment-resistant mental health disorders including depression and posttraumatic stress disorder (PTSD).

3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ‘ecstasy’ or ‘molly’ on the streets, and psilocybin, an active component of psychedelic mushrooms, have been abused illicitly for years, and remain illegal in situations other than being formally prescribed by a medical professional. However, psychedelics have been gaining significant media attention as of late as ongoing clinical trials are proving their properties have benefits for psychological health.

For example, psilocybin was found to reduce symptoms of depression by over 71%, according to Johns Hopkins University researchers, when combined with other forms of therapy. The study, published in the Journal of Psychopharmacology, was released in February 2022.

Australia TGA Approves Psychedelics for Mental Health Treatment
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Assistant professor of psychiatry and behavioral sciences at the university’s school of medicine, Natalie Gukasyan, said at the time, “Our findings add to evidence that, under carefully controlled conditions, this is a promising therapeutic approach that can lead to significant and durable improvements in depression…However, the results we see are in a research setting and require quite a lot of preparation and structured support from trained clinicians and therapists, and people should not attempt to try it on their own.”

On the other hand, patients with a history of PTSD found their symptoms improved 88% while using MDMA, according to a Phase III trial by the Department of Neurology in UC Davis published in 2021. And a review of 14 different studies published in 2020 mentions that although there was not enough evidence to support large scale prescriptions for these drugs, the results in favor appear to be promising.

Before formal approval, the TGA took into consideration thousands of letters written from the public regarding the issue.

“The number of such submissions is a reasonable indicator of the scope and gravity of the issues for individual and public health,” the agency responded. “The submissions confirm the need for greater access to alternative treatments for patients with persistent mental health conditions where currently available treatments have not been effective.”

The TGA continued, “Prescribing will be limited to psychiatrists, given their specialized qualifications and expertise to diagnose and treat patients with serious mental health conditions.”

That being said, no clinically approved medication containing these drugs is available yet in the Australian market, and critics contend that more studies should be undertaken before final approval.

Richard Bryant from the School of Psychology at the University of New South Wales has concerns over the use of psychedelics for mental health treatment, stating, “The science is at a point where we can say it is too early to be prescribing MDMA for PTSD patients. Instead, we should be investing in research to understand how MDMA can be used in relation to proven treatments.”


MDMA and Psilocybin assisted Psychotherapy Approved in Australia for Treatment Resistant Depression and PTSD

TGA approves psilocybin and MDMA for use in treating depression and PTSD

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