Australia approves MDMA, psilocybin for therapeutic use

Regulators in Australia announced this week that qualified psychiatrists will be able to prescribe “medication containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine)… for the treatment of certain mental illnesses” later this year.

Among the newly authorized uses, these substances are “listed in the Poisons Standard as Schedule 8 (Controlled Drugs) drugs,” but they remain “in Schedule 9 (Prohibited Substances), which largely restricts their supply to clinical trials” for all other uses.

The Therapeutic Goods Administration, Australia’s regulator of medicines and therapies in the country, announced on Friday that the substances’ reclassification will take effect on July 1.

“Prescribing will be limited to psychiatrists given their specific skills and expertise in diagnosing and treating patients with serious mental illness with therapies that are not yet well established. In order to prescribe, psychiatrists must be licensed under the Authorized Prescriber Scheme by the TGA after being approved by a human research ethics committee. The Authorized Prescriber Scheme allows prescribing authorizations to be issued under strict controls that ensure patient safety,” the announcement said.

The government said it will “allow the prescription of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression,” which it sees as “the only conditions where there is currently sufficient evidence of potential benefits in certain patients.” .”

“The decision recognizes the current lack of options for patients with certain treatment-resistant mental illnesses. This means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelics-assisted psychotherapy, which requires controls to protect these patients,” the administration said in Friday’s announcement.

“The decision follows requests to the TGA to reclassify the substances in the poison standard, extensive public consultation, a report from a panel of experts and advice from the Advisory Committee on Drug Planning,” the regulator continued. “Currently, there are no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and effectiveness. However, this change will allow authorized psychiatrists to access a specific ‘unlicensed’ drug containing these substances and legally supply it to patients under their care for these specific uses.”

The administration said the changes in the classification of the substances “were made by a senior medical officer of the TGA, who has been mandated by the Secretary of the Department of Health and Aged Care to exercise his authority to make decisions about the scheduling of drugs on the poisons standard.”

“The decision maker recognized that there is a need to access new therapies for treatment-resistant disorders such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Psychotherapy using psilocybin and MDMA has been shown to be potentially beneficial in the treatment of these conditions,” the administration said. “However, as with all drugs, there are risks with psilocybin and MDMA. Although these substances themselves are relatively safe when administered in the doses administered in conjunction with psychotherapy and in a medically controlled setting, patients are in an altered state of consciousness when they undergo psychedelics-assisted psychotherapy. It was decided that by restricting prescribing to licensed psychiatrists and for TRD or PTSD, the benefits to patients and public health will outweigh the risks.”

The announced policy change comes at a time when lawmakers in Australia are preparing a push to legalize cannabis in the country.

Australia’s Budget Office released a report detailing two potential plans to legalize cannabis and lay the groundwork for a regulated retail marijuana market.