Psilocybin, Australian re scheduling

Re-scheduling of psilocybin and MDMA

On 3 February 2023, TGA

Permit prescribing of MDMA for the treatment of post-traumatic stress disorder (PTSD)

Psilocybin for treatment-resistant depression (TRD)

Psychiatrists who are specifically authorised under the TGA’s Authorised Prescriber scheme,

effective from 1 July 2023.

Legal psilocybin prescriptions in Canada

(January 2022)

The SAP allows healthcare practitioners to request limited access to drugs that are not authorized for sale in Canada.

Treatment-resistant depression (TRD) is common

Responsible for much of the burden of major depressive disorder worldwide.

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial

Clinically significant anxiety and depression

Common in patients with cancer

Associated with poor psychiatric and medical outcomes

Double-blind, placebo-controlled trial

Intervention

Single-dose psilocybin (0.3 mg/kg),

70 Kg = 21mg

in conjunction with psychotherapy.

Assessed at 7 weeks

Psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression,

and led to decreases in cancer-related demoralization and hopelessness,

improved spiritual wellbeing,

and increased quality of life.

At the 6.5-month follow-up

Psilocybin was associated with enduring anxiolytic and anti-depressant effects,

60–80% of participants continued with clinically significant reductions in depression or anxiety,

sustained benefits in existential distress and quality of life,

as well as improved attitudes towards death.

The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression.

Trial Registration: ClinicalTrials.gov Identifier: NCT00957359

Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists

Medicines containing the psychedelic substances psilocybin,

and MDMA (3,4-methylenedioxy-methamphetamine)

Only conditions, currently sufficient evidence

For potential benefits in certain patients,

MDMA for treatment of post-traumatic stress disorder

Psilocybin for treatment-resistant depression

Acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses

Patients may be vulnerable during psychedelic-assisted psychotherapy,

requiring controls to protect these patients.

There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy.

However, this amendment will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses.