Australia becomes first country to allow MDMA and psilocybin treatment

Two illicit substances best known for their ‘recreational’ use have been given the tick of approval by Australian authorities to be prescribed for the treatment of post-traumatic stress disorder (PTSD) and depression.

Following the announcement in February, one that surprised many scientists, the Therapeutic Goods Administration (TGA) – the country’s FDA – has authorized the use of psilocybin and 3,4-methylenedioxy-methamphetamine (MDMA), which came into effect on July 1. However, access will be limited to those who meet certain mental health criteria and can only be prescribed by authorized psychiatrists.

Psilocybin, the psychoactive compound in the fungus more commonly known as magic mushrooms, is now permitted to be prescribed for depression that has proven resistant to other treatments. MDMA, meanwhile, can be administered to assist in the treatment of PTSD, a condition that arises out of trauma that’s notoriously difficult to treat in many patients. In 2020, an estimated 13 million US adults had PTSD.

“There is some compelling research, the evidence is growing, and psychedelic-assisted therapy may offer hope to a small number of patients where other treatments have been attempted without lasting success,” said Professor Richard Harvey, Chair of the The Royal Australian and New Zealand College of Psychiatrists’ (RANZCP’s) Psychedelic-Assisted Therapy Steering Group. “But psychedelic-assisted therapy is not a miracle cure that promises rapid recovery. People, and potentially very vulnerable people, can understandably feel distressed or let down if their experience does not match their expectations of this therapy.

“There is potential for psychedelic substances to cause fear, panic and re-traumatization,” he added. “Without careful clinical judgement and clear communication with people seeking treatment, there are risks.”

It’s hardly a July 1 free-for-all, however. For the therapeutic uses listed above, psilocybin and MDMA become Schedule 8 (Controlled Drugs) medicines, yet remain Schedule 9 (Prohibited Substances) and all but illegal for their use beyond approved clinical trials.

The TGA hasn’t evaluated or approved any products containing psilocybin or MDMA for safety and efficacy, however, authorized psychiatrists will be able to access a legal amount of ‘unapproved’ medicine that contains these compounds.

While several countries have moved forward with trials of these kinds of therapies, it’s still a fledgling area of medicine; Australia is now the first to move the field beyond clinical trials and other small exemptions to nationally regulate the drugs for use. 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.

“Psychedelic-assisted therapy is in its infancy,” Harvey said. “There is more we need to know, and it’s paramount that treatment only occur in highly supportive and structured environments, comparable to what you’d see in a clinical trial setting.”

Sources: TGA, Nature, RANZCP

Source of Article