TGA approves psilocybin, MDMA for mental health treatment

From July this year, medicines containing psilocybin and MDMA will be able to be prescribed by psychiatrists for mental health treatment, the Australian Therapeutic Goods Administration (TGA) has announced.

MDMA is being approved for the treatment of PTSD and psilocybin is approved for treatment-resistant depression. MDMA is frequently referred to as “ecstasy”: and psilocybin is the main ingredient in what some people refer to as “magic mushrooms.”

MDMA and magic mushrooms can be dangerous, and these compounds should only be prescribed by a psychiatrist.

This decision makes Australia the first country to officially recognise the two drugs as medicines.

“Recognising that illegal drugs like MDMA and psilocybin have medical utility is an important step in drug policy reform; however, the safe provision of these treatments requires extensive training, which is why they have been limited to clinical research in Australia to date,” says Edith Cowan University addiction researcher Dr Stephen Bright.

“To ensure that people accessing these treatments are not harmed, it will be important that the TGA provides a clear expectation regarding the minimum training standards required for psychiatrists who the TGA approves to prescribe these drugs.”

Other researchers are excited by the news.

“The safe ‘re-medicalisation’ of certain historically illicit drugs is a very welcome step away from what has been decades of demonisation,” says Dr David Caldicott, an Emergency Consultant and Senior Clinical Lecturer in Medicine at the Australian National University.

“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’.”

This is only a year after a controversial decision by the TGA that MDMA and psilocybin would not be rescheduled from a from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines).

The TGA has now confirmed that for the specific uses in PTSD and treatment resistant depression, psilocybin and MDMA will be listed as Schedule 8 (Controlled Medicines), but for all other uses, they will remain in Schedule 9 (Prohibited Substances).

There’s also a number of psychedelic start-ups in Australia that have been calling for change in this space for the last few years.

“There is initial evidence that MDMA can be beneficial in treating PTSD but there is much we do not know. We currently have strong evidence-based treatments for PTSD, and to date, we do not know how MDMA compares relative to these proven treatments which are much cheaper and simpler to administer,” says University of New South Wales psychologist Professor Richard Bryant.

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.”