Magic Mushrooms and MDMA could be approved for mental health conditions by TGA
They are currently prohibited, but magic mushrooms and MDMA could be legalised to help treat mental health conditions in Australia.
National
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Prohibited mind-altering drugs MDMA and Psilocybin (Magic Mushrooms) have moved a step closer to being approved for use in mental health in Australia as early as December.
Medicine regulator the Therapeutic Goods Administration released its review of the drugs which found they “showed promise” when used under close clinical supervision.
When compared to treatment with a placebo the improvement in patients treated with the prohibited drugs was ”statistically significant”, the review released on Thursday found.
Mind Medicine Australia (MMA), a charity formed by Soprano and social entrepreneur Tania de Jong and investment banker Peter Hunt have been campaigning for the drugs to be used in treating certain conditions like Post Traumatic Stress Disorder.
The TGA review found in doses higher than 100 mg MDMA resulted in statistically significant improvement in Post Traumatic Stress Disorder.
It also made a statistically significant difference in the condition in adults with autism who suffered social anxiety.
However, the results for anxiety in life threatening disease were non-significant, the review found.
The main adverse effects were anxiety, restlessness, fatigue, jaw-clenching, headache and transient increases in blood pressure.
“Serious events such as suicidal ideation were rare and occurred almost entirely in the placebo arm or were otherwise unrelated to the therapy,” the review said.
Psilocybin produced a statistically significant improvement in the condition of people with treatment-resistant depression in people with anxiety or depression in life threatening disease.
It was found to be superior to remaining on a waitlist and to be equally effective as a registered antidepressant (escitalopram).
However, there was no significant effect of dose on obsessive-compulsive symptoms, the review found.
The main side effects were anxiety, headache and transient increases in blood pressure.
The TGA review said it was important to note the 9 small studies it reviewed were conducted “ in highly supportive and structured environments including intense psychotherapy sessions in many cases”.
“We conclude that MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support,” the review said.
The Executive Director of MMA, Tania de Jong AM said current mental health treatments don’t work for many Australians and there is increasing suffering and suicides in our community.
“ Our Health Practitioners desperately need new treatment options. We have a serious mental health emergency in Australia and people need some hope for healing,” she said.
“Psilocybin assisted therapy (primarily for treatment resistant depression and end of life anxiety) and MDMA assisted therapy (primarily for treatment resistant post-traumatic stress disorder) have both shown remission outcomes of 60-80% in overseas trials after just two to three medicinal sessions in combination with a short course of psychotherapy. As the Panel has observed, these medicines are very safe and well tolerated by patients in a clinical environment,” she said.
Peter Hunt said the charity was hopeful that these medicinal therapies will now be rescheduled as controlled medicines under the Poisons Standard.
“This will enable psychiatrists who are already getting approvals from the TGA, to treat seriously ill and suicidal patients under its Special Access Scheme on a case-by-case basis, to apply for individual permits from State and Territory Governments around Australia,” he said.
“What we need now is a nationally standardised approach for providing medical approvals to those who are suffering desperately,” he said.
A final decision on whether they will be down scheduled from a prohibited substance to one that can be used under clinical supervision will be announced in December.
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