New avenue for alternative medicine

6 February 2023 10:20

A new avenue has opened up in Australia for alternative medicine producers, with the Therapeutic Goods Administration permiting the prescription of MDMA for the treatment of post-traumatic stress disorder and psilocybin, more commonly known as magic mushrooms, for treatment-resistant depression in controlled medical settings.

The decision comes from an independent expert panel report on the therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental, behavioural or developmental disorders for patients with specific treatment-resistant mental illnesses who currently lack treatment options.

When the decision comes into effect on the first of July, Australia will become the first market in the world to recognise psychedelics as medicine.

This decision has come earlier than anyone in the industry suspected as the TGA previously moved to limit the use of MDMA and psilocybin to clinical trials in December of 2021.

This surprising change of direction gives the companies already working with MDMA and psilocybin a significant head-start on the competition.

One such company is Little Green Pharma subsidiary Reset Mind Sciences, which is now in the advanced stages of preparing a clinical trial for the use of psilocybin as a prescription for treatment-resistant depression which has now been identified as permissible for treatment under the TGA’s new parameters.

This unexpected change uniquely positions Reset Mind Sciences due to its Schedule 9 licence which authorises it to cultivate and supply psilocybin, allowing it to accelerate plans for commercialisation ahead of schedule.

The company said it welcomes the TGA’s decision to down-schedule psilocybin and MDMA.

“There is a significant body of research emerging in Australia and globally for the use of psychedelics to treat mental health conditions and this decision allows the use of these drugs for the mental health conditions that have demonstrated the most potential in the research,” chief executive Shaun Duffy said.

“We’re still working through the full implications of the TGA’s decision for our strategy moving forward but suffice it to say it’s a very positive development for us and will result in an acceleration of our plans.”

The TGA’s announcement has seen the LGP’s share price jump 40 per cent today, currently trading at 0.26c (10.04 am UTC + hours).

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