Australia Offers MDMA Drug Therapy for PTSD, a World First

The Washington Post

15:59 JST, June 30, 2023

PERTH, Australia – The scientist held up the container of clear liquid and examined it. At a rave, it could be sold by its street names “ecstasy” or “molly.” But here, in a university lab in one of the most remote cities in the world, experts are harnessing MDMA with a therapeutic purpose in mind.

The team of chemists at the University of Western Australia have been working to modify the chemical compound so it can be better used for mental health treatments.

It’s a mission that has suddenly became more urgent, after Australia announced it would become the first country to allow psychiatrists to widely prescribe MDMA to treat post-traumatic stress disorder.

“We will have a lot of attention on us as this rolls out,” said Michael Winlo, the chief executive of Australian biotech company Emyria, which is partly funding the lab’s work.

Australia’s drug regulator, the Therapeutic Goods Administration, surprised just about everybody – including the country’s health institutions – when it ruled that from July, MDMA would be rescheduled from a prohibited to a controlled substance. It will also allow psilocybin, the active ingredient in magic mushrooms, to be used in therapy for treatment-resistant depression.

In doing so, the regulator has turned Australia into a countrywide experiment for other jurisdictions, including the United States, to observe. That is especially the case for MDMA, which no nation has made accessible as a mental health treatment except in limited special circumstances, and which has been of increasing interest to the Food and Drug Administration.

Some experts believe the law change in Australia has happened too quickly and could put patients at risk. But the drugs’ advocates say the move could offer recovery to people with debilitating mental illnesses.

MDMA floods the brain with feel-good chemicals it produces naturally: serotonin, norepinephrine, oxytocin and dopamine. Meanwhile, fear is curtailed: the amygdala, the brain’s threat response system, quietens down.

It’s a cocktail that, practitioners say, allows a patient to examine past traumatic experiences while typical responses like avoidance, defensiveness and shame are blocked.

A 2021 clinical trial published in Nature of people with severe PTSD found 88 percent showed significant improvement after three sessions of MDMA-assisted therapy. More than two-thirds no longer met the criteria for PTSD two months afterward.

The U.S.-based Multidisciplinary Association for Psychedelic Studies (MAPS), the organization that has applied for FDA approval, sponsored the research.

There is also ongoing research into MDMA’s potential in the treatment of addiction, social anxiety and, in the case of the UWA-Emyria lab, Parkinson’s disease. In all, the global psychedelics market is projected to be worth more than $10 billion by 2027.

“It’s a pretty hot area,” said Matthew Piggott, associate professor of medicinal chemistry and the head of the lab at the University of Western Australia.

His team is working on shortening MDMA’s half-life (the length of time the drug is in effect) and eliminating a weak addictive property. In the lab, a chemist carefully pours a clear solution into a flask from a series of test tubes. Inside, each contains an analog of the drug. Nearby, a colleague handles a small jar filled with crystalline yellow precursor, while another switches off a contraption with a spinning sphere.

The work has helped turn the state capital Perth, a city with thousands of miles of desert on one side and the Indian Ocean on the other, into an unlikely vanguard of the nascent psychedelic therapies industry.

The state’s favorable regulatory approach has meant Australian-based biotech companies working in MDMA and psilocybin have set up there, said Suzy Madar, an intellectual property lawyer who specializes in health.

But the companies were still surprised when the drugs were rescheduled in February.

“It’s not common for the TGA to take a lead in this kind of area,” said Winlo of Emyria. “This puts a lot of attention on the various players in this space to see how we proceed.”

Some experts are concerned Australia has not designed an adequate regulatory framework for this type of treatment.

“Those of us at the coalface doing this research can see how there are going to be very few guardrails in place,” said Paul Liknaitzky, head of clinical psychedelic research at Monash University and co-founder of psychedelic therapy business Clarion Clinics.

“The safety and quality of what is provided is going to depend in large part on the goodwill and competence of the providers, not on authorities and governance,” he said.

The TGA, the drugs regulator that operates at arm’s length from government, made the rescheduling decision. It provided some guidance, but its involvement in overseeing MDMA and psilocybin therapies has now largely ceased.

Instead, human research ethics committees – of which there are about 200 in Australia – will be responsible for assessing psychiatrists’ applications to become authorized prescribers, with final TGA sign-off.

One concern expressed by experts is equality of access: Treatments are initially expected to cost about $17,000 for those incorporating standard therapy sessions before and after the drug is taken and multiple dosing sessions lasting about eight hours each.

Another concern is the potential for boundaries to be crossed. Australian clinics planning on offering MDMA therapy for PTSD said they would be adapting from the treatment manual published by MAPS, the organization that has applied for FDA approval.

This method includes “nurturing touch” between the therapist and patient. That could include the patient being “held” by the therapist, or the therapist placing their hand “on an area where the participant is experiencing pain, tension or other physical symptoms.” Withholding touch could be perceived as “abuse by neglect,” it says.

It bars any sexual behavior between therapist and patient and requires prior and ongoing consent for touch. It recommends two therapists, generally one female and one male, be in the room for each dosing session, and that sessions be recorded.

The TGA said it was satisfied appropriate safeguards could be established in the existing system.

But Hester Wilson, alcohol and drug spokesperson for the Royal Australian College of General Practitioners, said the use of “nurturing touch” in an MDMA-assisted treatment worries her.

“If you’ve seen or been with people who are on MDMA, their boundaries are really blurred. They’re so emotionally vulnerable, and just telling everybody that they love them,” Wilson said.

Still, the apparent potential of MDMA to help people who have not responded to other treatment is attractive to many.

At the Pax Centre, a trauma-focused clinic in Perth, co-founders Claire Kullack and Jon Laugharne have undertaken training, along with 18 staff members, and received ethics committee approval for the therapy, using a clinical trial model with recorded, two-therapist sessions and partnering with Emyria, the biotech firm.

About 20 to 30 percent of their clients with PTSD showed little improvement with available treatment methods, Laugharne said. The clinic is cautiously optimistic they may now be able to give some of those people a fuller life.

“We’re at the forefront of something – for once,” he said dryly, referring to Australia. “It’s exciting, and it’s also a big responsibility.”