Australia’s version of the FDA surprised the nation in early February when they announced that psilocybin and MDMA would be considered medicines, and prescribable by psychiatrists for various mental health disorders by July.
Psilocybin, the psychoactive component in psychedelic mushrooms, and MDMA, commonly known as ecstasy, are two of the most effective treatments for dangerous and persistent mental health disorders like treatment-resistant depression and PTSD.
The current illegality of these substances in most countries makes them difficult to study in large trials, but small ones have been universally successful.
For psilocybin, Johns Hopkins University found it reduced symptoms of depression by 71% when combined with assisted psychotherapy, and prevented any return in symptoms in 54% of trial participants.
In 2021, the Department of Neurology at UC San Francisco also concluded a phase III trial of MDMA-assisted psychotherapy for victims of PTSD and found it improved symptoms by 88%, and smashed the FDA criteria for safe and effective.
The Australian Therapeutic Goods Administration (TGA) said it considered several thousands of written public submissions before making its decision.
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“The number of such submissions is a reasonable indicator of the scope and gravity of the issues for individual and public health,” it said in a statement. “The submissions confirm the need for greater access to alternative treatments for patients with persistent mental health conditions where currently available treatments have not been effective.”
“Prescribing will be limited to psychiatrists, given their specialized qualifications and expertise to diagnose and treat patients with serious mental health conditions.”
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