Systematic literature review of the therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions
The Therapeutic Goods Administration (TGA) Scheduling Delegate (decision maker) has 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.
Timing of final decision
The Panel’s report will be considered by the Advisory Committee of Medicines Scheduling (ACMS) at the 3 November 2021 meeting. The Delegate’s final decision is anticipated to be published the first week of December 2021.
mmda-psilocybin-independent-expert-panel-review-final-reportTerms 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.
Panel Members
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.
Contact details
For enquiries regarding the review or to contact the Panel please email MDMApsilocybinreview@health.gov.au(link sends e-mail).
Commentary By Mind Med Australia
We had some great news last week! Following Mind Medicine Australia’s applications to the TGA to reschedule MDMA and psilocybin for the treatment of key mental health disorders, the TGA have just released the Independent Review on the therapeutic value, benefits and risks of these medicines.
These findings strongly support our application to reschedule these medicines from Schedule 9 prohibited substances, to schedule 8 controlled medicines.
You can read our full media release and see the TGA’s full report here >>
And read more recent NEWS articles here.
Sean, this is a step in the right direction and we thank you for your support in achieving this significant milestone.
We could not have done it without you.
The ultimate decision will be made in December. Given our increasing mental health emergency, equitable access to these treatments has never been more important.
This is why we are delighted to invite you to our International Summit on Psychedelic Therapies for Mental Illness and 2-day Introductory Workshop Program in Psychedelic Therapies this November 17th – 20th.
The Summit and Workshop are completely virtual, meaning no matter what happens with lockdowns and travel restrictions, you can be part of this movement to shift the paradigm and usher in a quantum leap in mental health treatment.
We’ve just released the full program, and are incredibly proud of the world class Faculty we’ve brought to inspire and educate you on these breakthrough treatments for mental health.
You can see the program and get your Summit and workshop tickets here >>
