As of July, Australians suffering from certain mental health conditions can ask their psychiatrist to prescribe psilocybin and MDMA.
The Australian Government’s Therapeutic Goods Administration announced Friday it will allow psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression.
For the specific uses, the substances will be listed as controlled drugs under Schedule 8 medicines in the Poisons Standard. For all other uses –except clinical trials– the substances will remain under Schedule 9 which encloses prohibited substances.
“These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,” reads an announcement by the administration.
Psychiatrists will be the only ones able to prescribe them and they will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.
The authorised prescriber scheme allows prescribing permissions to be granted under strict control to ensure patient safety.
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The decision comes after noticing a lack of options for patients with specific treatment-resistant mental illnesses. It also follows applications made to the TGA to reclassify the substances, an extensive public consultation, a report from a panel of experts and advice received from the Advisory Committee on Medicines Scheduling.
Currently, there are no products containing psilocybin or MDMA that have been evaluated for quality, safety and efficacy but the amendment will allow psychiatrists to access and legally supply a specified ’unapproved’ medicine to patients.
Psychiatrists will need a license and a permit to import the drugs and once that is in place, an application to obtain an import permit may be submitted for each shipment.
Some Australian psychedelics companies and organizations are already running psilocybin clinical trials in the country including the Swinburne University of Technology which announced Monday that it had signed an AUD$5 million clinical trial agreement with Sydney’s Woke Pharmaceuticals. The large-scale clinical trial is testing a rapid-release tablet that could treat treatment-resistant depression.