MDMA, Psilocybin Authorized as Medicines in Australia

MDMA and psilocybin, widely used as recreational drugs, have been officially approved in Australia for treating mental illnesses.

Australia's Therapeutic Goods Administration (TGA) announced last week that from July 1, 2023, psilocybin is approved as a medication for treatment-resistant depression (TRD), while MDMA can be used to treat post-traumatic stress disorder (PTSD).

Both psilocybin and MDMA, or 3,4-Methyl​enedioxy​methamphetamine, are primarily used as recreational drugs. In recent years, researchers have been increasingly studying these psychedelics for their possible benefits on mental health.

For now, only psychiatrists who have been authorized under the Authorized Prescriber Scheme will be able to prescribe MDMA and psilocybin. This means that psychiatrists will have to be granted approval from the Human Research Ethics Committee (HREC) and then TGA.

Moreover, psychiatrists are expected to have considered all clinically appropriate treatment options before applying to access a psilocybin — or MDMA — containing product for their patient.

The TGA's announcement cites a recent study published in the New England Journal of Medicine which indicates that a single psilocybin dose of 25 mg "reduced depression scores significantly more than a 1 mg dose over a period of 3 weeks."

In most studies on microdosing psilocybin — self-administering the substance in low doses that do not impair a person's "normal functioning" — participants reported improved mental health. However, controlled studies suggest that this may be simply a placebo effect.

The largest study on psilocybin benefits to date was published last June in the journal Nature. Researchers followed nearly 1,000 participants who took small doses of psilocybin and a group of controls taking non-psychedelic substances. Self-evaluation after 30 days revealed that microdosing participants, especially women, reported greater improvement in depression, anxiety, and stress.

Currently, psilocybin is classified as a Schedule I substance in the U.S., despite being available as a prescription drug under the name Indocybin® in the 1960s.

Another study suggests that MDMA-assisted therapy is highly effective and well-tolerated in people with PTSD. About five out of 100 adults in the U.S. suffer from the disorder in any given year. Women are more likely to develop PTSD than men, and the condition is more prevalent among veterans than civilians.