TGA Considers Rescheduling Psychedelic Drugs

Australia’s medical regulator, the Therapeutic Goods Administration (TGA), may be opening the door to therapeutic use of psychedelic and psychoactive drugs this month. The TGA is meeting tomorrow to discuss an expert report submitted on 30 September, with a final decision from the meeting expected in December.

The proposal before the TGA is to change MDMA and psilocybin (active ingredient in ‘shrooms) from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines). This would allow them to be legally used in medical treatments – as are cocaine, ketamine, opioids and amphetamines – once their safety and efficacy is confirmed.

The export report to the TGA considered published research on dosing with MDMA or psilocybin as a catalyst to psychotherapy. Focus conditions for this kind of psychedelic psychotherapy include OCD, PTSD, depression, social anxiety, and anxiety or depression in patients with life-threatening disease.

The study review noted that in MDMA studies, adverse events such as thoughts of suicide occurred only in the group given a placebo, rather than the MDMA. Psilocybin was seen to be effective against depression, although one study was confounded when a low-dose of psilocybin given as a placebo was found to be as effective as a high dose.

The export review concluded, “MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.”

Australian advocacy group PRISM was also cautiously supportive. “Without an established and integrated system of clinical governance for the provision of psychedelics, rescheduling alone may open the door to unethical and unsafe practices,” commented PRISM’s Dr Stephen Bright. “Appropriate training in this novel and paradigm-changing approach is still broadly lacking, even among mental health professionals.”

MAPS is the leading advocate and funder of psychedelic research in the United States.

MAPS – the Multidisciplinary Association for Psychedelic Studies – is the leading advocate for psychedelic medicines. In May this year, a MAPS-funded Phase 3 study published in Nature found that “MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated.”

MDMA-assisted therapy for PTSD has leveraged the special political support enjoyed by military veterans. Research has progressed rapidly after it earned “breakthrough therapy” status in the US in 2017.

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