Australia makes history as the first county to categorize the psychedelics MDMA and psilocybin as medicine for use in treating mental health conditions.
Australia’s Therapeutic Goods Administration (TGA) has approved two psychedelic substances for administration by qualified mental health care practitioners for treatment of certain mental health conditions, the agency said today.
“From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions,” read the statement.
Under the ruling, MDMA will be approved for use to treat post-traumatic stress disorder (PTSD), and psilocybin for treatment-resistant depression, moving them to Schedule 8 classifications. Both substances will still be considered prohibited substances — or Schedule 9 drugs — for all other uses including recreational use.
“Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions,” TGA said.
Psychiatrists will need to be approved by the TGA’s authorized prescriber scheme in order to administer or prescribe the use of the substances.
“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses,” TGA said. “It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.
“For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials,” read the TGA statement.
Treatment-resistant depression affects about 30 percent of patients. It is diagnosed as two or more pharmaceutical antidepressants that fail to relieve symptoms.
TGA made the decision following a report from a panel of experts, thousands of public comments, and advice from the Advisory Committee on Medicines Scheduling.
While the approval signals a step forward in alternative treatments, TGA has not yet looked at products that contain psilocybin or MDMA. This will mean that for the time being, psychiatrists wanting to prescribe the substances will have to supply patients with unapproved medicines, which could pose risks in quality and efficacy.
“The conditions for which these drugs might be used [post-traumatic stress disorder and treatment-resistant depression] are currently conditions for which you’re basically destined to a lifetime of drug use. Whereas the MDMA particularly is used to facilitate psychotherapy, only for a few doses,” Associate Professor David Caldicott told the Sydney Morning Herald. Caldicott is an emergency department doctor who has advocated for use of psychedelics to help treat soldiers suffering from PTSD.
Demand for psychedelics to treat mental health issues has been steadily increasing as studies prove their efficacy and cities relax laws around recreational use. Celebrities including Green Bay Packers quarterback Aaron Rodgers have gone public with their use of psychedelics, further spotlighting their potential in treating a range of issues.
Psilocybin, the psychedelic substance found in hundreds of mushroom species, and MDMA, the substance in the party drug Ecstasy, have both been widely studied. A Johns Hopkins study published last year in the Journal of Psychopharmacology found that psilocybin-assisted psychotherapy could lead to “significant and durable improvements in depression.”
Psilocybin has also shown benefits in relieving symptoms of depression for months after a single dose, and in helping terminal cancer patients cope.
MDMA has been the focus of U.S.-based MAPS, the Multidisciplinary Association of Psychedelic Studies. Its research has centered on treating PTSD sufferers, particularly combat veterans. The organization has conducted Phase 3 clinical trials on MDMA — the final step before a drug goes to the FDA for approval.
In 2020, Oregon voters approved legalizing the therapeutic use of psilocybin in a U.S.-first. That law went into effect at the beginning of this year. A number of U.S. cities have also decriminalized psychedelics for recreational use, making them the lowest priority for law enforcement.
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