The Australia story: Current status and future challenges for the clinical applications of psychedelics
David Nutt, Peter Hunt, Anne Katrin Schlag, Paul Fitzgerald
British Journal of Pharmacology December 19, 2024 DOI: 10.1111/bph.17398 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | MDMA Psilocybin |
| Keywords | Psychedelic therapy psychedelics Hallucinogens Entheogens Therapeutic goods administration Medical regulations Psychiatric 3,4‐Methylenedioxymethamphetamine MDMA Australia Mental health treatment |
| Citations | 21 |
| Key findings | The Australian TGA approved psilocybin for treatment-resistant depression and MDMA for PTSD in 2023, with prescribing restricted to authorized psychiatrists. |
Abstract
Abstract 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.
Comparable studies
Other narrative reviews on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Human Pharmacology of MDMA | 2004 | Review | |
| Human psychopharmacology of Ecstasy (MDMA): a review of 15 years of empirical research | 2001 | Review | |
| 3,4‐Methylenedioxymethamphetamine (MDMA, “Ecstasy”): pharmacology and toxicology in animals and humans | 1994 | Review | |
| (±)3,4-Methylenedioxymethamphetamine (‘Ecstasy’)-Induced Serotonin Neurotoxicity: Studies in Animals | 2000 | Review | |
| Amphetamine toxicities | 2010 | Review |
Citations in the library
Cited by 18
- Key competencies for psychedelic treatment in real-world mental health care settings. General Hospital Psychiatry 2025
- Regulatory Challenges of Integrating Psychedelics into Mental Health Sector Psychoactives April 22, 2025
- The Legal Perspective on Psilocybin for Medical Use in Czechia: A Key Milestone and the Case for Broader Consideration Beyond the Clinical Setting Psychoactives September 11, 2025
- Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty. The Journal of Law, Medicine & Ethics 2026
- Pathway engineering for the biosynthesis of psychedelics Current Opinion in Biotechnology May 15, 2025
and 13 more in the library
Cites 10
- Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine November 3, 2022
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial Psychological Medicine June 15, 2018
- Single-Dose Psilocybin Treatment for Major Depressive Disorder JAMA August 31, 2023
- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine October 1, 2023
and 5 more in the library