MDMA and psilocybin approved for medical use by Australia

SYDNEY: In a groundbreaking move, Australia has become the first country to authorise the use of MDMA and psilocybin, substances typically associated with recreational use, for the treatment of post-traumatic stress disorder (PTSD) and depression.

The Therapeutic Goods Administration (TGA), Australia’s equivalent to the FDA, announced this surprising decision in February, with the new regulations taking effect today.

The use of these substances will be strictly controlled, with prescriptions limited to those meeting specific mental health criteria and only authorised psychiatrists permitted to prescribe them. Psilocybin, the psychoactive compound found in ‘magic mushrooms’, can now be prescribed for treatment-resistant depression. Meanwhile, MDMA can be used to assist in the treatment of PTSD, a condition notoriously difficult to treat.

Despite the potential benefits, Professor Richard Harvey, Chair of the The Royal Australian and New Zealand College of Psychiatrists’ (RANZCP’s) Psychedelic-Assisted Therapy Steering Group, warned that psychedelic-assisted therapy is not a miracle cure and carries risks, including the potential to cause fear, panic, and re-traumatisation.

The substances will be classified as Schedule 8 (Controlled Drugs) for therapeutic use but remain Schedule 9 (Prohibited Substances) for all other uses. The TGA has not evaluated or approved any products containing psilocybin or MDMA for safety and efficacy. However, authorised psychiatrists will be able to access a legal amount of ‘unapproved’ medicine containing these compounds.

Australia’s move is a significant step forward in a fledgling area of medicine. In 2021, the Australian government invested AUD15 million (US$10 million) in grants for researchers to study the benefits of drugs such as psilocybin, MDMA, and ketamine. Despite this progress, Professor Harvey emphasised that psychedelic-assisted therapy is still in its infancy and that treatment should only occur in highly supportive and structured environments.

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