World-first psychedelics treatment approved for PTSD and depression

The move has been largely welcomed with cautious optimism, providing hope to those for whom ‘gold-standard’ treatments for PTSD or depression have not worked.

Psilocybin, otherwise known as magic mushrooms. The Therapeutic Goods Administrator has approved limited use as approved medicines. Picture: Supplied

Australians could be the first in the world to access psychedelics as ­approved medicines, following an announcement from the national medicines regulator that authorised psychiatrists will be able to prescribe psilocybin and MDMA from July this year.

The move has been welcomed with cautious optimism by most medical researchers.

Kim Felmingham, chair of clinical psychology at the University of Melbourne, called it a “promising and exciting development”.

The Therapeutic Goods Administration says it will limit the prescription of MDMA (ecstasy) to the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.

“These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,” the regulator said in a statement. The decision comes amid a broader review of classifications in the poisons standard following expert advice, an “extensive” public consultation, and a report from an expert panel.

The TGA also issued an interim decision to reduce the maximum packet size of paracetamol instead of entirely “upscheduling” the product, which would have made it more difficult to access.

The limited authorisation of psychedelics comes after years of agitation from researchers about the healing properties of select substances like MDMA and psilocybin – otherwise known as magic mushrooms. They said those healing properties were particularly valuable for patient cases where other treatments had not worked.

“Developing novel treatments for PTSD is sorely needed, particularly for PTSD patients for whom our gold-standard treatments have failed,” Prof Felmingham said.

“However, further rigorous ­research is required to understand the mechanisms underpinning MDMA-assisted therapy, so we can address the critical question of what therapy works for each individual with PTSD.”

The TGA said the green light acknowledged the “current lack of options for patients with specific treatment-resistant mental illnesses.”

Psychiatrists will have to seek authorisation under the TGA’s authorised prescriber scheme after approval from an ethics committee.

Paul Liknaitzky, head of clinical psychedelic research at Monash University, said his research showed “the potential of (psychedelic-assisted) treatment to change people’s lives for the better”.

But he also urged caution.

“The safety and effectiveness of psychedelic therapies depends on a unique set of professional competencies and considerations that are in scarce supply within mental healthcare,” Dr Liknaitzky said. Edith Cowan University’s Stephen Bright said Australia was now “the first country in the world to officially recognise MDMA and psilocybins as medicines”.

Beyond prescriptions permitted under the strict guidelines, psilocybin and MDMA, often used as illicit party drugs, will remain a prohibited substance and will be largely restricted except for use in clinical trials.

Professor Richard Bryant from UNSW. Picture: Claudia Baxter

The UNSW’s Richard Bryant said the decision was “too early” and more research was needed.

“The science is at a point where we can say it is too early to be prescribing MDMA for PTSD patients,” he said.

“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 ... we do not know how MDMA compares relative to these proven treatments.”