Australia Becomes First Country to Reclassify MDMA and ‘Magic Mushrooms’ for Medical Use

Ecstasy tablets which may contain MDMA DEA

Australia will become the first country to reclassify medicines containing methylenedioxymethamphetamine, more commonly known as MDMA (ecstasy) and psilocybin, to treat certain mental health conditions.

The Therapeutic Goods Administration (TGA) announced on Feb. 3 that they will permit authorised psychiatrists to prescribe MDMA for Post Traumatic Stress Disorder (PTSD) and psilocybin for treatment-resistant depression.

MDMA is the active ingredient found in the party drug ecstasy, and psilocybin is the active ingredient found in psychedelic “magic” mushrooms.

From July 1, authorised psychiatrists with specialised qualifications and expertise to diagnose and treat patients with severe mental health conditions will be able to prescribe medicines containing these psychedelic substances.

This comes despite those therapies not being well established.

MDMA and psilocybin are still listed as prohibited substances, but all other legal uses will remain limited to clinical trials.

To prescribe MDMA and psilocybin, psychiatrists must be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

Authorised Prescribers by the TGA are allowed to prescribe medication and supply therapeutic goods to specified patients under strict controls to ensure the safety of patients. Authorised prescribers must also report the number of patients treated every six months to TGA.

Biggest Trial into Effects of Psychedelics

Australia’s Swinburne University has signed a $5 million (US$3.46 million) clinical research trial with Woke Pharmaceuticals into the effects of psilocybin, the active ingredient in psychedelic mushrooms, in treating treatment-resistant depression.

Commencing in mid-2023, this trial will be the biggest research agreement in this area in Australia, with approximately 160 patients who will participate in a randomised controlled trial of either two or three doses of psilocybin for psychotherapy versus a placebo.

During the trial, the psilocybin drug candidate WP002 will be used via a formulated rapid-release tablet by the pharmaceutical company.

“Psychedelics could transform the landscape of treatments for many psychiatric disorders, including major depression,” said Prof. Susan Rossell, the lead researcher of the research trial.

“The initial positive findings from the literature need to be pursued with large real-world trials, like the one we are conducting. Exploring the effectiveness of two or three dosing sessions will provide critical data on the sustainability of benefit and effective real-world treatment regimens of psilocybin-assisted psychotherapy for those with treatment-resistant depression.”

Further, as funding and the clinical material will be supplied by Woke Pharmaceuticals, this will enable Swinburne University to collaborate with Monash University and the University of Tasmania on the research.

Not Enough Long-Term Data

However, the TGA’s decision to list the psychedelics has been met with mixed reactions by researchers and academics in the medical field, including the study’s lead researcher.

Rossell has said she is concerned about broadening the treatment at a larger scale without long-term data to analyse.

“I have a significant degree of caution about this decision because these treatments are not well established at all for a sufficient level of broad-scale implementation. Substantial further research needs to be done,” said Rossell in her comments published on Scimex.

“First, to confirm efficacy to international standards for all psychotropic medications and to understand which conditions are best treated and which formulations will best serve the patients and minimise risks. We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study.”

Further Research is Required on the Effects

Enterprise Fellow at the University of South Australia’s Clinical and Health Sciences, Mike Musker, said the long-awaited access to MDMA and psilocybin would offer relief to many who experience PTSD and depression—especially army veterans and those who have worked in emergency services but who have not been treated with standard psychiatric medication.

“The prescribing of these drugs has been prohibited for use by government drug agencies (TGA, FDA) even though early research over the last two decades has produced some promising results, the resistance to their use has remained,” Musker said.

“The journal ‘Nature’ suggested that these drugs are “shaking up psychiatry” by providing treatments for conditions which were previously seen as intractable. There are risks, however, with any new drug, and there is a potential that using a mind-altering drug can lead to psychosis, which has been seen with drugs like cannabis.”

Melbourne University’s Chair of Clinical Psychology, Prof. Kim Felmingham, said the approval of MDMA-assisted therapy for PTSD is promising and exciting, based on positive clinical results, but needed additional research to understand the mechanisms underpinning MDMA-assisted therapy to address what therapy works for each individual with PTSD.

“No one PTSD treatment is a panacea that will treat everyone with PTSD effectively, and MDMA is not an exception,” he said.

“Additional research on this topic would allow us to streamline our health resources, direct people to the most effective treatment for them and improve the accessibility of treatments for people living with PTSD.”

Meanwhile, Prof. Richard Bryant from the University of New South Wales School of Psychology said the science is at a point where we can say it is too early to be prescribing MDMA for PTSD patients.

“Instead, we should be investing in research to understand how MDMA can be used in relation to proven treatments,” Bryant said.