Australia will become the first country to reclassify medicines containing methylenedioxymethamphetamine, more commonly known as MDMA (ecstasy) and psilocybin, to treat certain mental health conditions.
The Therapeutic Goods Administration (TGA) announced on Feb. 3 that they will permit authorised psychiatrists to prescribe MDMA for Post Traumatic Stress Disorder (PTSD) and psilocybin for treatment-resistant depression.
MDMA is the active ingredient found in the party drug ecstasy, and psilocybin is the active ingredient found in psychedelic “magic” mushrooms.
From July 1, authorised psychiatrists with specialised qualifications and expertise to diagnose and treat patients with severe mental health conditions will be able to prescribe medicines containing these psychedelic substances.
This comes despite those therapies not being well established.
MDMA and psilocybin are still listed as prohibited substances, but all other legal uses will remain limited to clinical trials.
To prescribe MDMA and psilocybin, psychiatrists must be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.
Authorised Prescribers by the TGA are allowed to prescribe medication and supply therapeutic goods to specified patients under strict controls to ensure the safety of patients. Authorised prescribers must also report the number of patients treated every six months to TGA.
Australia’s Swinburne University has signed a $5 million (US$3.46 million) clinical research trial with Woke Pharmaceuticals into the effects of psilocybin, the active ingredient in psychedelic mushrooms, in treating treatment-resistant depression.
Commencing in mid-2023, this trial will be the biggest research agreement in this area in Australia, with approximately 160 patients who will participate in a randomised controlled trial of either two or three doses of psilocybin for psychotherapy versus a placebo.
During the trial, the psilocybin drug candidate WP002 will be used via a formulated rapid-release tablet by the pharmaceutical company.
“Psychedelics could transform the landscape of treatments for many psychiatric disorders, including major depression,” said Prof. Susan Rossell, the lead researcher of the research trial.
“The initial positive findings from the literature need to be pursued with large real-world trials, like the one we are conducting. Exploring the effectiveness of two or three dosing sessions will provide critical data on the sustainability of benefit and effective real-world treatment regimens of psilocybin-assisted psychotherapy for those with treatment-resistant depression.”
However, the TGA’s decision to list the psychedelics has been met with mixed reactions by researchers and academics in the medical field, including the study’s lead researcher.
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