In a groundbreaking development, Australia is to reclassify psilocybin and MDMA to enable prescribing by authorised psychiatrists.
Under the new classification, the substances will change from Schedule 9 which is prohibited substances, to Schedule 8, which is controlled drugs, of the Poisons Standard. The change will take effect from 1 July, 2023.
Under the new classification, Australia’s Therapeutic Goods Administration (TGA) will permit prescribing of MDMA for post-traumatic stress disorder (PTSD), and will permit prescribing of psilocybin for treatment-resistant depression.
Acknowledging the current lack of options for patients with specific treatment-resistant mental illnesses, the TGA has stated that these two conditions are the only ones for which there is currently sufficient evidence for potential benefits in certain patients.
How will it work?
According to a statement from the TGA, prescribing will be limited to psychiatrists “given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established”.
It has also confirmed that any psychiatrists that want to prescribe these therapies will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.
Access to psychedelic therapies for Australians
The news has been welcomed by the industry in Australia, which has been pushing for a change in scheduling.
The decision was made following multiple applications to the TGA to reclassify the substances in the Poisons Standard, as well as public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.
Australian-based psychedelics company, Mind Medicine Australia, made a statement saying: “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.
“We want to express our enormous gratitude to the tens of thousands of people who have made this breakthrough possible including the TGA, the Delegate, the members of the TGA’s Medicines Scheduling Advisory Committee and all of the psychiatrists, psychologists, other mental health professionals, world-leading experts and all of the people who put in submissions of support.
“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.”
PharmAla Biotech Holdings CEO, Nick Kadysh, stated: “This is a critically important announcement by the TGA, allowing for the direct prescription and treatment of patients with PTSD and Treatment-Resistant Depression with Psychedelic molecules.
“As the registered supplier to three different Australian clinical trials using MDMA – more than any other Psychedelics API supplier – PharmAla is the only company which has both GMP MDMA and Psilocybin in inventory, and stands ready to ship these molecules to Australia.”
COO of PharmAla Biotech, Dr Shane Morris, added: “The TGA decision absolutely sets a new global standard for treatment with molecules like MDMA and Psilocybin.
“Allowing specially-licensed psychiatrists to prescribe these molecules directly to patients is an excellent approach, and will certainly help drive other countries to re-assess how they regulate these molecules to meet patients’ medical needs.”
