This review (2024) examines the recent approval by the Australian Therapeutic Goods Administration (TGA) of psilocybin for treatment-resistant depression (TRD) and MDMA for PTSD, effective 1 July 2023. It highlights the campaign led by Mind Medicine Australia and supported by leading researchers and institutions, as well as implications for future approvals and psychedelic drug development pathways.
Abstract of The Australia story
“The past decade has seen a huge increase in clinical research with psychedelic drugs and 3,4-methylenedioxymethamphetamine (MDMA), which have revealed great potential for treating mental health conditions. Given this progress in research, as well as the current unmet clinical need of millions of patients, in 2023, the Australian Therapeutic Goods Administration (TGA) approved the use of psilocybin for treatment-resistant depression and MDMA for PTSD to take effect from 1 July 2023. The campaign for TGA approval was led by a coalition comprising the Australian charity Mind Medicine Australia with support from Professor David Nutt, Drug Science, Professor Arthur Christopolous, Professor Chris Langmead (both from Monash University) and from large numbers of clinical, academic and patient groups. Under the rescheduling, current prescribing rights are limited to psychiatrists who have become authorised prescribers under the TGA’s Authorised Prescriber Scheme, and psilocybin can only be used for treatment resistant depression and MDMA can only be used for PTSD. This paper reviews the background for this decision, its implications for approvals in other jurisdictions, as well as for the development pathways for other psychedelic drugs.”
Authors: David J. Nutt, Peter Hunt, Anne Katrin Schlag & Paul B. Fitzgerald
Summary of The Australia story
This 2024 review (submitted in Q1) examines the growing interest in the clinical application of psychedelics, particularly psilocybin and MDMA, for treating mental health conditions. It highlights the lack of significant pharmacological advances in psychiatric treatments over the past five decades and underscores the increasing burden of mental illness. Recent clinical trials have demonstrated the rapid and powerful therapeutic effects of psychedelics, prompting pharmaceutical companies to pursue regulatory approval.
The focus of the article is Australia’s landmark decision to approve psilocybin for treatment-resistant depression and MDMA for PTSD, effective from 1 July 2023. The Therapeutic Goods Administration (TGA) implemented this rescheduling to address unmet clinical needs. The authors outline the regulatory journey leading to this decision and explore its broader implications for international approvals and further drug development.
Background to the Australian Decision
Find this paper
https://doi.org/10.1111/bph.17398
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Cite this paper (APA)
Nutt, D. J., Hunt, P., Schlag, A. K., & Fitzgerald, P. The Australia story: Current status and future challenges for the clinical applications of psychedelics. British journal of pharmacology.
Study details
Compounds studied
Psilocybin
MDMA