TGA approves MDMA, psilocybin for mental health treatment

TGA approves MDMA, psilocybin for mental health treatment

Australia’s therapeutics regulator has announced today that psychiatrists will soon be able to prescribe psychedelic drugs MDMA and psilocybin to treat patients suffering from post-traumatic stress disorder (PTSD) and depression.

The decision by the Therapeutic Goods Administration (TGA) will come into effect from 1 July and will allow psychiatrists to prescribe MDMA for the treatment of PTSD and psilocybin – a substance naturally occurring in magic mushrooms - for treatment-resistant depression.

It also comes more than a year after biotechnology company Emyria (ASX: EMD) partnered with the University of Western Australia to study how 100 MDMA-like compounds can help treat patients suffering from PTSD and Parkinson's disease.

Backed by Australian billionaire Andrew ‘Twiggy’ Forrest, the Perth-based company is also working with Mind Medicines Australia to deliver a psychedelic-assisted therapy care program for those who suffer from PTSD.

Off the back of the news, Emyria’s shares rose by as much as 11 per cent earlier today before softening to land at 19 cents each on the close of trade.

“This is a significant decision from the TGA, which means that under specific circumstances research into these substances will now be more possible,” Emyria CEO Michael Winlo said.

“We believe MDMA and psilocybin, when used in combination with psychotherapy, have numerous possible therapeutic uses for mental health conditions, which is crucial as the global mental health crisis continues to worsen.”

Prescribing either psychedelic will be exclusively limited to psychiatrists, who will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

For all other uses, both drugs will remain listed as a prohibited substances (Schedule 9), which largely restricts their supply to clinical trials.

“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses,” the TGA said.

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

To date, there are no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy.

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