Key Point
- MDMA and psilocybin are reclassified as medicines for some mental health conditions in Australia.
- The TGA announced the changes on Friday, saying they would go into effect on July 1.
- Both drugs continue to be classified as prohibited substances.
Australia becomes the first country in the world to approve MDMA, the active ingredient in the party drug Ecstasy, as a treatment for post-traumatic stress disorder (PTSD).
Starting July 1, Therapeutic Goods Administration (TGA) will allow specially licensed psychiatrists to prescribe aka methylenedioxymethamphetamine, psilocybin, the active ingredient in PTSD and psychedelic mushrooms, and treatment-resistant depression.
The two drugs continue to be classified as prohibited substances, otherwise their legal use remains limited to clinical trials.
The TGA ruling, announced Friday afternoon, sparked immediate and mixed reactions from medical researchers and academics.
Professor Susan Rossell of Swinburne University, who is leading Australia’s largest trial of psilocybin’s effects on depression, is concerned that more research is needed.
“These therapies are not well established to be implemented at sufficient levels and on a large scale,” she said.
“We don’t have any data on long-term results, so I’m very concerned. This is one of the reasons I’m doing such a large study.
Meanwhile, Associate Professor David Caldicott of the Australian National University said the change in classification represents an inevitable consequence that could have happened many years ago.
“MDMA was banned by executive order of the President of the United States in 1985, and was used as a pharmaceutical drug in defiance of the advice of medical professionals and government agencies.
“Perhaps most excitingly, many of the treatments emerging in these previously banned products require only brief exposures to facilitate treatment, blunt the edge of psychological trauma. You don’t need a lifelong prescription for the only drug you can get.
Certain psychiatrists are also allowed to prescribe psilocybin, the active ingredient in psychedelic mushrooms, for treatment-resistant depression. sauce: Getty / bloomberg creative
Dr. Paul Liknaitzky leads the Clinical Psychedelics Research Project at Monash University. This project is already providing psychedelic-assisted therapy to clinical patients.
“While we have seen first-hand the potential for our treatments to change people’s lives for the better, the safety and effectiveness of psychedelic therapy depend on the professional competencies and skills that mental health care lacks. It depends on its own set of considerations,” he said.
“For psychedelic clinical services to be sensible, safe, and useful, significant professional and public education is required, addressing issues of affordability, eligibility, oversight, and standards of care. need to do it.
“This schedule change is coming in a matter of months, so Australia has little time to figure this out.”
Professor Kim Felmingham, professor of clinical psychology at the University of Melbourne, said the reclassification of MDMA was exciting and promising, but additional research was needed.
“There is no one-size-fits-all PTSD drug that effectively treats all PTSD patients, and MDMA is no exception,” said Professor Fermingham.
“Additional research on this topic will help streamline healthcare resources, direct people to the most effective treatments, and improve access to treatment for people living with PTSD.”
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https://www.sbs.com.au/news/article/australia-will-reclassify-mdma-as-medicine-in-a-world-first-experts-have-mixed-views/9ja389o21 Australia will be the first country in the world to reclassify MDMA as a medicinal product.Expert opinion is mixed
