Australia recently made history when it categorized psychedelics as medicines, becoming the first country in the world to grant the distinction to hallucinogenic drugs. Psychedelics have been subject to an increasing amount of research in recent years amid a rising push for alternative mental health treatments. Hallucinogenic drugs such as psilocybin and ketamine have exhibited a range of potential medical benefits against mental health disorders in a variety of clinical trials.
However, the fact that these substances are largely illegal worldwide has hindered further research and made it nearly impossible for people who could benefit from psychedelic-assisted therapies to access them.
In Australia, however, the country’s Therapeutic Goods Administration (TGA) made the bold and unprecedented choice to approve the use of psychedelic substances to address certain mental health conditions. The TGA has approved the use of MDMA and psilocybin (the main psychoactive agent in magic mushrooms) to alleviate the symptoms of selected mental health disorders.
Both psilocybin and MDMA will be rescheduled as Schedule 8 drugs and will be available for medical use with the approval of a licensed psychiatrist beginning July 2023.
The Therapeutic Goods Administration acknowledged that there are few effective treatment alternatives for people suffering from treatment-resistant mental illnesses and stated that these two psychedelics could be safe and effective alternatives. The department announced in a recent statement that only psychiatrists will have the authority to prescribe psychedelic treatments for patients dealing with severe mental health conditions. In addition, psychiatrists will first have to receive approval from the Therapeutic Goods Administration’s authorized prescriber scene.
Psychedelic Research in Science and Medicine director Stephen Bright stated that the decision to acknowledge psychedelics as medicines was unprecedented as the country was very conservative. However, the TGA has provided little detail on psychedelic products that could function as safe and effective treatments, meaning psychiatrists will be responsible for sourcing and supplying authorized patients with unapproved medicines. Bright also noted that aside from himself and a few other psychiatrists, no one had received the training that would allow them to prescribe and oversee psychedelic-assisted therapies for their patients.
Associate professor David Caldicott stated that he was pleasantly surprised by the department’s decision, stating that the defense against using MDMA in medicine has been chiefly propagated by politics not science. Caldicott is an emergency department physician who argued the benefits of providing psychedelic therapies to returning soldiers to help them deal with psychological trauma before the Royal Commission into Defence and Veteran Suicide.
He noted that a few doses of MDMA may be used to alleviate conditions such as treatment-resistant depression and post-traumatic stress disorder, which may have doomed the patient to a life of drug use.
With countries beginning to recognize different psychedelics as medicinal, startups such as Compass Pathways PLC (NASDAQ: CMPS) will have a welcoming environment by the time the formulations they are developing obtain regulatory approval.
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