The Scheduling Delegate has now made a final decision on the scheduling of MDMA and psilocybin.
The Therapeutic Goods Administration (TGA) Scheduling Delegate (decision maker) deferred the final decision on applications to down-schedule MDMA and psilocybin from schedule 9 (prohibited drug) to schedule 8 (controlled drug) pending a review into the therapeutic value, risks and benefits to public health outcomes for these substances. On 5 August 2021, the TGA announced that an Independent Expert Panel had been established to undertake the review. The review has now been completed and the Panel's report is published below.
Independent Expert Panel Report
An evaluation of the therapeutic value, benefits and risks of methylenedioxymethamphetamine (MDMA) and psilocybin for the treatment of mental, behavioural or developmental disorders.
Amendment to Expert Panel Report and Summary
This report was amended by the Panel on 15 October 2021 to correct minor errors that were identified following its publication. The Panel considers that the amendments do not change the conclusions previously published. The amendments are:
- Page 5 - Second and third paragraphs have been refined to more accurately characterise the comparative effects of psilocybin relative to escitalopram on depression remission and response rates, further described below.
- Page 12 - MDMA quality assessment amended to correct the number of studies with conclusions meeting the threshold of statistical significance referenced in the report. The incorrect reference to Supplementary Table 2 has been corrected to Supplementary Table 3.
- Page 15-17 - Figure 8 has been amended at 2.6.6 to correct an error, which decreases the P-value for psilocybin vs SSRI. This is further reflected in the amendment to the text in this section to more accurately describe the effect of psilocybin vs active placebo, and the effect of psilocybin relative to escitalopram, in depression remission and response rates.
- Page 17 - The wording of the sensitivity analysis section has been amended to improve clarity.
- Page 19 - A "corrections" section has been added to the report, outlining the changes described above.
These corrections were also applied to the Summary of the Panel Report
- Page 2 - The first paragraph for the MDMA results has been corrected to clarify that "half the studies" refers to studies on PTSD.
- Page 3 - Second and third paragraphs for the psilocybin results have been amended to more accurately characterise the comparative effects of psilocybin relative to escitalopram on depression remission and response rates.
The Panel's report was considered by the Advisory Committee of Medicines Scheduling (ACMS) at the 3 November 2021 meeting. The Delegate's final decision has now been published.
Terms of Reference
The Independent Expert Panel was established to undertake a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions.
The review is to report findings on the current state of the evidence of therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions, including the size of effect, the quality of evidence and the applicability of the evidence to real-world use in Australia, currently and into the future.
The review excludes pre-clinical trials (i.e. experimental pharmacology studies in test tube or animal models).
The Panel is not a decision making or approval body, and their role is to provide a publicly available report which will be considered by the delegate and the Advisory Committee for Medicines Scheduling.
Professor Mark Connor
Professor Mark Connor is a molecular pharmacologist with expertise in analgesics and psychoactive drugs, particularly cannabinoids and opioids, with extensive research experience in the USA, UK, and Australia. Currently, his work focuses on the pharmacology of synthetic cannabinoids and the molecular effects of phytocannabinoids.
Professor Connor holds a Bachelor of Science (Hons) and PhD in Pharmacology. He is currently the Associate Dean, Higher Degree Research, Department of Biomedical Sciences, Macquarie University.
Professor Steve Kisely
Professor Steve Kisely is a psychiatrist and public health physician with health services research experience in the UK, Australia, and Canada. He obtained fellowship of the relevant Colleges in the UK, Australasia and Canada, as well as of the Australasian Chapter of Addiction Medicine. He is also an accredited member of the faculties of adult psychiatry, addiction (FAP) and consultation psychiatry (FCLP) of the Royal Australian & New Zealand College of Psychiatrists.
Professor Kisely holds a Doctor of Medicine (Research Doctor of Philosophy and Doctor of Medicine. Professor Kisely is currently Professor of Psychiatry, School of Medicine, The University of Queensland.
Professor Andrew Somogyi
Professor Andrew Somogyi Professor Somogyi is Professor in Clinical and Experimental Pharmacology. He is a practicing pharmacist and has a research program centred on elucidating the mechanisms and factors contributing to altered human drug response in pain therapeutics, infectious diseases, depression, and transplantation through pharmacokinetic, metabolism, pharmacodynamic and pharmacogenomic studies. He is a member of the Editorial Advisory Committee and Company Director of the Australian Medicines Handbook.
Professor Somogyi holds a Certificate of Pharmacy, Diploma of Hospital Pharmacy, Master of Science, and a PhD (Clinical Pharmacology). Professor Somogyi is currently a Professor of Pharmacology, Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide.
For enquiries regarding the review or to contact the Panel please email MDMApsilocybinreview@health.gov.au.