New overseas clinical trial results add weight to the Therapeutic Goods Administration's (TGA) February 2023 decision to reschedule MDMA and psilocybin as Schedule 8 Controlled Medicines.
These substances have now been authorised for use in therapy for post-traumatic stress disorder (PTSD) and treatment-resistant depression.
Data bolsters support
The TGA's decision was initially based on comprehensive evidence from Mind Medicine Australia, the TGA's independent investigations and more than 13,000 public submissions, 98% of which supported the rescheduling. Now, two major overseas trials have fortified this stance.
In the Multidisciplinary Association for Psychedelic Studies (MAPS) Second Stage Phase 3 Trial, published in Nature Medicine on September 14, 2023, MDMA-assisted therapy showed promising results.
Specifically, 86.2% of participants in the MDMA group reported improved symptoms compared to 69% in the placebo group. Additionally, 71.2% no longer met PTSD criteria, versus 47.6% in the placebo group.
A Phase 2 Trial by the Usona Institute, published in JAMA on August 31, 2023, evaluated psilocybin treatment for major depressive disorder.
The study confirmed rapid and sustained antidepressant effects of psilocybin, with no serious treatment-emergent adverse effects reported.
Regulatory and commercial implications
Both trials were backed by not-for-profit organisations and had received Breakthrough Therapy Status from the US Food and Drug Administration (FDA).
The trials are crucial for validating the TGA's more restricted approach to using these substances as unregistered medicines in Australia.
While MAPS plans to apply for MDMA's registration as a medicine in the United States, the Usona Institute's findings also suggest potential for future approvals.
Next steps
These studies lay the groundwork for further research and possible inclusion in mental health treatment protocols, answering a desperate call for more effective treatment options for debilitating mental illnesses.
For those who had advocated for the TGA's rescheduling, these results act as a timely vindication, pointing to a future where stigmatised substances could become vital tools in mental health treatment.