Australia's Psychedelics Therapy Provides Hope For Treatment-Resistant Mental Health Conditions

As of July 1, psilocybin and MDMA (and related substances to both) can now be prescribed by authorized psychiatrists in Australia, which has become the fourth government agency to enact a compassionate use program for psychedelic-assisted therapies to treat mental health conditions joining Israel, the US and Canada.

Following the Therapeutic Goods Administration (TGA)’s drug reclassifying decision, MDMA is now available for the treatment of PTSD, and psilocybin for cases of Treatment-Resistant Depression (TRD).

The procedure entails physicians getting approval under the TGA’s Authorized Prescriber Scheme, following approval by a human research ethics committee, to provide their patients with psilocybin and MDMA in a controlled medical setting after obtaining the patient’s informed consent and having “the training and expertise appropriate for the condition being treated and the proposed use of the product.”

Rescheduling is a result of extensive public consultation as well as a report from an expert panel and advice from the committee on medicines scheduling.

In the US, MAPS’ founder and director Rick Doblin predicted to Fox News that the FDA will approve MDMA-assisted therapy for PTSD by April-May 2024.

On the Australian news, Doblin said: “Australians who have endured long-standing psychological suffering will soon have the opportunity to consider emerging treatments backed by rigorous clinical research,” referring to the successful Phase 3 trials on MDMA therapy for PTSD and Phase 2 trials on psilocybin therapy for TRD. 

“Australia’s policy change is one that every country should consider: suffering people, regardless of nationality, need more opportunities to access novel treatments. We hope that this announcement will encourage more international discussion and collaboration towards access to psychedelic therapies and comprehensive drug policy reform.” 

Payton Nyquvest, co-founder and CEO of clinical research partner Numinus Wellness NUMIF shared his views with Benzinga.

“The TGA’s approval surrounding MDMA and psilocybin for specific and controlled usage is a welcome step forward for Australia as well as the entire mental health field,” said Nyquvest. “This decision impacts the millions of people who are enduring treatment-resistant mental health conditions and opens a pathway to profoundly change their lives. I look forward to watching progress being made on a global scale as a result of our industry’s collective mission to help the world heal.”

Australia is one of the most active countries in terms of assessing the benefits of psychedelics in advanced clinical trials including the first health insurance provider to consider psychedelics therapy coverage for mental health conditions back in July 2022.

Photo: Benzinga edit with photo by Augusto Cabral, eskymaks and billion photos on Shutterstock.