Australia Becomes First Country To Approve Psychedelics For Patients With Depression And PTSD


John Oyewale Contributor
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Australia on Saturday became the first country in the world to approve the prescription of certain psychedelics for patients with depression and post-traumatic stress disorder (PTSD).

“[S]pecifically authorised psychiatrists,” selected following approval by a human research ethics committee, would be permitted to “prescribe MDMA [otherwise known as ecstasy] for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression”, according to a statement from Australia’s Therapeutic Goods Administration (TGA). The statement was initially released Feb. 3, but only went into effect July 1, the Associated Press (AP) reported.

The permission would be granted to those authorized psychiatrists “under strict controls that ensure the safety of patients,” because the patients “may be vulnerable during psychedelic-assisted psychotherapy.” Both drugs — MDMA and psilocybin — would be reclassified as “Controlled Drugs” strictly in the context of treating PTSD and depression, respectively. The two drugs would remain classified as “Prohibited Substances” for all other uses, according to the TGA statement.

The substances could provide “potential benefits” in treating PTSD and chronic depression based on “currently sufficient evidence.” Prescribing psychiatrists would be selected based on their “specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established,” the statement reads. (RELATED: ‘It’s Getting Worse Every Day’: Drug Use And Crime Strain Portland Business Owners)

The TGA acknowledged there were “currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy” as of February, but that the reclassification of the substances would “allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses.”

Scientists in Australia were reportedly surprised by the decision, with one saying it put Australia “at the forefront of research in this field,” according to AP.

The U.S. Food and Drug Administration (FDA) appears to be mulling over the potential of MDMA, psilocybin and lysergic acid diethylamide (LSD) for therapeutic use, as it issued a draft guidance in June 2023 “for drug development programs evaluating the therapeutic potential of psychedelic drugs.” The draft was published to gather comments from and provide general guidance to experts but “does not establish any rights for any person and is not binding on FDA or the public.”

Oregon became the first state to legalize the therapeutic use of psilocybin and to decriminalize various hard drugs, including heroin and methamphetamine, in November 2020. Colorado followed in November 2022, decriminalizing psychedelic mushrooms for users 21 and older.