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TGA Approves Psilocybin, MDMA for Mental Health Treatment

Elliot Nash, 8 Feb 2023 | News

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To the surprise of many in the healthcare community, mushrooms and ecstasy will be available by prescription from authorised psychiatrists to treat depression and post-traumatic stress disorder (PTSD) in controlled conditions from 1 July. Much like the approval of Medicinal Cannabis back in 2016, Australia’s medical regulator shock decision has opened the door to alternative mental health treatments following the promising results from international studies investigating the role MDMA and Psilocybin can play in treating mental health conditions. However, this doesn’t mean mushies and molly are about to flood the streets. Only authorised psychiatrists in supervised medical settings have approved the use of the medications. So what exactly does this mean for the Australian health system and those suffering from mental health conditions?

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The Therapeutic Goods Administration (TGA) recently approved the use of psilocybin, a compound found in psychotropic “magic” mushrooms, to treat depression, and MDMA, the active ingredient in party drugs such as “ecstasy” or “molly”, to treat post-traumatic stress disorder (PTSD). Now considered schedule 8 drugs, psilocybin and MDMA are now approved for controlled use when prescribed by a psychiatrist from 1 July.

According to the TGA website, “there is a need for access to new therapies for treatment-resistant conditions such as treatment-resistant depression and post-traumatic stress disorder,” addressing the “lack of options” for people with some mental illnesses that did not respond to other treatments.

“Psychotherapy involving psilocybin and MDMA has shown to be potentially beneficial in the treatment of these conditions.”

The decision has been met with excitement from mental health professionals and patients alike, as the use of these substances has shown promising results in clinical trials.

“It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting,” the TGA said.”However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.”

What is Psilocybin and MDMA?

Psilocybin is a naturally occurring psychedelic compound found in certain types of mushrooms. It has been used for centuries in traditional healing practices and has positively affected mood and mental health. Surprisingly, MDMA first hit the market in 1912 as an appetite suppressant. However, we all know it’s been used experimentally as a party drug and therapeutically, despite being criminalised in most countries following its ban in the USA in 1985.

3,4-methylenedioxy-methamphetamine (MDMA), also known as ecstasy, is a synthetic substance often used recreationally for its euphoric effects. However, in recent years, it has also been studied for its therapeutic potential, particularly in treating PTSD. Australia is home to several species of magic mushrooms. However, possession or supply is illegal.

The Science Behind Psilocybin and MDMA in Mental Health Treatment

Studies have shown that psilocybin can help to reduce anxiety and depression in patients. It works by altering the brain’s serotonin levels, which can positively impact mood and emotional regulation. Studies have shown that MDMA can effectively treat PTSD by allowing patients to confront and process traumatic experiences in a safe and controlled environment. The substance may also help to increase feelings of empathy and trust, allowing patients to engage in therapy and work through their traumas.

The TGA Approval Process

Approving these substances for therapeutic use was a rigorous process involving extensive clinical trials and a thorough assessment by the TGA of the potential risks and benefits. The decision was based on the best available evidence, and the TGA is confident that patients can use these substances safely and effectively to treat depression and PTSD.

“The number of such submissions is a reasonable indicator of the scope and gravity of the issues for individual and public health,” said the TGA.  “The submissions confirm the need for greater access to alternative treatments for patients with persistent mental health conditions where currently available treatments have not been effective.”

It’s a decision that also considers the reclassification of previously prohibited drugs, like the approval of medicinal cannabis in 2016.

Potential Benefits of Psilocybin and MDMA Treatment

Traditional treatments like SSRIs and regular therapy are ineffective for a third of depressed individuals who develop “treatment-resistant depression”. The approval of psilocybin and MDMA for therapeutic use has the potential to revolutionise the mental health field, especially for those resistant to traditional treatments. These substances offer a new, innovative approach to treating depression and PTSD that can be more effective than conventional methods. Additionally, they have the potential to reduce the stigma associated with mental health treatment and encourage more people to seek help.

Weighing Up The Risks

The TGA has not yet authorised any psilocybin or MDMA-containing products after assessing their quality, safety, and effectiveness. However, this amendment will make it legal for licenced psychiatrists to obtain and give patients under their care a specific “unapproved” drug containing these ingredients for these particular applications.

Those worried about “bad trips” and the anecdotal effects of party drugs should remember that the TGA provides strict guidelines for all approved medications dispensed in Australia. As for those in the unapproved category, the TGA website states, “medical practitioners” that are “granted authority” to prescribe unapproved therapeutic goods “must report the number of patients treated every six months.”

According to the TGA, the decision to approve the therapy was taken because, for certain patients, the advantages of using these medications under a psychiatrist’s guidance outweighed the dangers. “Clinical investigations have shown promise when they (MDMA and psilocybin) are administered in conjunction with psychotherapy carried out in highly regulated medical settings”.

Despite the strict controls, some health professionals warn that more research is needed, especially regarding long-term outcomes and side effects, an argument that mirrors the debate around e-cigarettes.

That being said, the TGA’s decision will open the door to better research of psychedelic treatments, enabling psychiatrists to treat their patients better and provide them with the appropriate medications for their mental health conditions.

Prescribing MDMA and Psilocybin

A human research ethics committee must first authorise psychiatrists under Australia’s Authorised Prescriber Scheme, and then the TGA must also approve them. They must demonstrate that the treatment plan can be clinically justified, that good governance will be in place over the treatment process, and the psychiatrist will take the appropriate safeguards to protect patients.

Outside of these controlled conditions, MDMA and psilocybin are still prohibited as schedule 9 drugs, so don’t expect to see them outside the doctor’s office. And besides, we still don’t know how much these treatments will cost. Nor whether they will be covered by health insurance.

But it’s still earlier days for psilocybin and MDMA mental health treatments. There is still plenty to learn from using psychedelics. We look forward to seeing its impact on Australian health care.