MDMA and magic mushrooms have been approved for use by psychiatrists to treat some mental health conditions.
The Therapeutic Goods Administration has approved the prescription of MDMA for treating post-traumatic stress disorder and psilocybin, which is the active ingredient in magic mushrooms, for treatment-resistant depression.
The change in law will come into force on July 1.
The two drugs are still classified as prohibited and outside of psychiatrist treatments they will only be legally allowed in clinical trials.
The Therapeutic Goods Administration has approved the prescription of MDMA for treating post-traumatic stress disorder
The TGA ruling, announced on Friday afternoon, prompted mixed reaction from medical researchers and academics.
The Mind Medicine Australia team, who lodged an application for the change in law, celebrated its approval.
A statement from the group read: ‘We are delighted with the decision which will be welcomed by so many suffering Australians. It specifically recognises the current lack of options for patients with specific treatment-resistant mental illnesses and the supporting evidence of safety and efficacy from clinical trials.
‘The support that we have had throughout this process has been incredible and overwhelming.
‘Finally, our hearts go out to all those Australians suffering from treatment resistant depression and treatment resistant post-traumatic stress disorder. They will now have the opportunity of accessing this breakthrough treatment with their mental health professionals, which has shown such positive safety and efficacy results internationally.’
However, Swinburne University Professor Susan Rossell, who leads Australia’s biggest trial on the effects of psilocybin on depression, is concerned more research needed to be done.
‘These treatments are not well established at all for a sufficient level of broad-scale implementation,’ she said.
‘We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study.’
Psilocybin, which is the active ingredient in magic mushrooms, will be used for treatment-resistant depression
Meanwhile, Australian National University associate professor David Caldicott said the classification change represented an inevitable outcome that could have occurred years ago.
‘MDMA was being used as medication in 1985, when it was banned by executive order of the President of the USA, and against the advice of medical professionals and administrative agencies,’ he said.
‘Perhaps most excitingly, many of the treatments that are emerging with these previously banned products require only a brief exposure to facilitate therapy, and not the life-long prescription of drugs that do little more than dull the edge of psychological trauma.’
Dr Paul Liknaitzky leads Monash University’s clinical psychedelic research project, which already delivers psychedelic-assisted therapies to clinical patients.
‘We have witnessed up-close the potential of our treatment to change people’s lives for the better; yet the safety and effectiveness of psychedelic therapies depends on a unique set of professional competencies and considerations that are in scarce supply within mental healthcare,’ he said.
‘For clinical psychedelic services to be sensible, safe and useful, considerable professional and public education will be needed, and questions of affordability, eligibility, oversight, and standards of care should be addressed.
‘With this schedule change coming in a matter of months, Australia has very little time to get across this.’
Melbourne University’s Chair of Clinical Psychology Professor Kim Felmingham said MDMA’s reclassification was both exciting and promising, but also called for additional reserach.
‘No one PTSD treatment is a panacea that will treat everyone with PTSD effectively and MDMA is not an exception,’ Prof Felmingham said.
‘Additional research on this topic would allow us to streamline our health resources, direct people to the most effective treatment for them and improve the accessibility of treatments for people living with PTSD.’
