The Australian government has signaled a new direction for the country’s view on psychedelics to treat certain mental health conditions.
The Therapeutic Goods Administration (TGA) will reschedule medicines containing psilocybin and MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.
The decision allows for the compounds to be used therapeutically in a controlled medical setting by authorized psychiatrists.
Psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) used for therapy will be reclassified as Schedule 8 (controlled drugs) medicines by July 1, 2023. The two will remain in Schedule 9 (prohibited substances) for all other uses, restricting supply to clinical trials.
“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses,” the agency wrote in a Feb. 3 statement. “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.”
The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, as well as advice received from the Advisory Committee on Medicines Scheduling.
There are currently no approved products containing MDMA or psilocybin that the agency has evaluated for quality, safety, and efficacy.
“This amendment will allow authorized psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses,” the agency said.
Philip J. Young, chairman and CEO of Vancouver-based psychedelics research company Lobe Sciences, on Monday, called the move an “important step by a national government recognizing the value of these compounds in treating certain mental health conditions.”
“As we prepare for a (phase 2) study in Australia…it’s heartening to know that there is already significant support for psychedelic compound,” Young added.
Prescribing will be limited to psychiatrists permitted under the Authorised Prescriber Scheme by the TGA, following approval by a human research ethics committee. The guidance allows prescribing permissions to be granted under strict controls that ensure patient safety.