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Treating mental health; TGA approves MDMA and Psilocybin as a medicine

Although it doesn’t apply to me, many of you may remember the early mornings during adolescence when you were throwing yourself around in a club, parading a locked-jaw, and beaming pupils so wide it would be hard to deny that you weren’t on something. Well, chances are, you had consumed MDMA, or if you were wild enough, a concoction of stimulants and psychedelics. 

So it may seem like a joke when I tell you that the very same substances that fuelled your venture into those wild club-runs as a teen, MDMA and Psilocybin, are now recognized by the TGA for the treatment of certain medical conditions.

Once again, nothing I have ever associated with (editor note: that he remembers). 

So with the latest news from the TGA (Therapeutic Goods Administration), the mental health treatment landscape is going through a revolution as psychiatrists have been given the authority to prescribe medicines containing the psychedelic substances Psilocybin and MDMA from 1 July 2023, for eligible patients suffering certain mental conditions; ushering in a new era modern mental health treatment.

If patients wish to ride the new wave, they will require a psychiatrist to diagnose them with either post-traumatic stress disorder or treatment-resistant depression – conditions that can be treated with the substances and have evidence suggesting potential benefits in some patients.

As the top priority, in order to maximise patient safety and to become approved as an authorised psychiatrist, permissions require approval from the Therapeutic Goods Administration (TGA) after being reviewed by a human research ethics committee – this is all part of The Authorised Prescriber Scheme’s (APS) stringent controls during treatment ensuring the safest route of administration is taken.

The APS scheme acts as the legal basis allowing prescribers access and supply of ‘unapproved’ therapeutic goods. Updated regularly, the scheme supports access to therapies such as; imported medicines and cosmetics, certain medical devices, as well as cannabis & psychedelics. 

Although a major step forward for pharmaceutical companies and their future clinical trials, the TGA classifies MDMA and Psilocybin as Schedule 8 (Controlled Drugs) medicine under the Poisons Standard for specified conditions. However, these same substances will remain Schedule 9 Prohibited Substances when used outside authorised research studies until they have undergone further evaluation on its safety and quality.

The landmark decision emphasises the importance of providing accessible, effective alternatives to managing mental health conditions in the safest way possible.

With this industry-shaking development hitting the markets today, investors have taken notice of drug discovery & developer company, Emyria Ltd (ASX: EMD), who at the time of writing, saw its share price jump by almost 80% – up from $0.17 to $0.32. Joining the rally and also reaping gains was Australian cannabis company Little Green Pharma (ASX: LGP), one of the biggest movers in this regard, jumped over 40% to its current levels at $0.26 after opening at $0.195 earlier today.

Jack Cornips

Trading Desk Assistant at Emerald Financial

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