Australia has taken a significant step by allowing the legal use of MDMA—commonly known as ecstasy— and psilocybin—the hallucinogenic compound found in ‘magic mushrooms’—for the treatment of post-traumatic stress disorder (PTSD) and treatment-resistant depression. This groundbreaking decision, authorized by Australia’s drug regulator, the Therapeutic Goods Administration (TGA), positions the country among the first in the world to recognize psychedelics as legitimate medical treatments, as reported in the press.
In March 2022, Mind Medicine Australia, a non-profit organization, submitted applications to the TGA to make MDMA and psilocybin legally available for therapeutic purposes. Finally, in February 2023, these applications were approved. Psychiatrists can apply to Australia’s Human Research Ethics Committees (HRECs) to become licensed prescribers of MDMA and psilocybin, with final approval resting with the TGA.
The TGA based its decision on “sufficient evidence” suggesting that these drugs could be beneficial for specific patients with PTSD and depression. As a result, MDMA and psilocybin has been reclassified from banned substances to controlled drugs, allowing them to be legally prescribed and used for specific purposes. Moreover, a pathway has been established for licensed psychiatrists to prescribe and administer these drugs in clinical settings. Psychedelic-based treatment have been active in Australia starting from July 1.
Similar to clinical trials, patients receiving psychedelics will be closely monitored by healthcare professionals in controlled environments during psychedelic-assisted therapy in Australia.
Australia’s allowance comes amid a growing body of research indicating that psilocybin could help patients with treatment-resistant depression, potentially by enhancing connectivity between different areas of the brain. For example, MDMA is understood to increase the activity of certain brain neurotransmitters, including serotonin, as well as hormones such as oxytocin and prolactin.
Recent studies suggest that these properties could aid in the treatment of PTSD by reducing levels of arousal and stress, allowing patients to overcome trauma.
Will The U.S. Food and Drug Administration Follow The TGA’s Lead?
Although Australia became the first western nation to liberalize psychedelic therapy to a mainstream degree, some scientists caution that there is still insufficient research. Thus, not everyone is onboard with Australia’s decision to license these drugs as medicines.
In the United States, treatment with psilocybin and MDMA is currently authorized in specific cases under compassionate use, which grants individual patients access to drugs being tested in clinical trials but not yet approved by the U.S. Food and Drug Administration (FDA). However, expanded use may be coming in 2024 as MAPS Benefit Public Benefit Corporation (MAPS PBC) is expected to file a New Adrug Application with the FDA for MDMA assisted therapy for sufferers of PTSD.
Should the application prove successful, MDMA therapy may become broadly used in specific mental health conditions, while opening the door to psilocybin therapy for depression down the road.
Despite this progress, concerns have been raised regarding the oversight of psychedelic-assisted therapies. Some experts argue that there is still a need for greater regulation and monitoring in these treatment settings. Nonetheless, Australia’s decision may serve as a model for other countries that have yet to approve the therapeutic use of psychedelics, potentially prompting them to reconsider their stance and follow suit.