Therapeutic Goods Administration approves MDMA prescription

The Therapeutic Goods Administration (TGA) announced on Friday the drugs would be removed from the Poisons Standard prohibited substances to the controlled medicines classification.

Psychiatrists will onwards from July 1 be allowed to prescribe these substances for treatment resistant depression and treatment resistant posttraumatic stress disorder.

The decision came after a Mind Medicine Australia rescheduling application in March 2022, supported by a large volume of submissions from Australia.

The TGA will permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression – the only conditions with sufficient evidence for potential benefits in certain patients.

Psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA to be able to make the prescriptions which will be possible only after approval by a human research ethics committee.

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

The amendment will however allow authorised psychiatrists to access and legally supply a specified ‘unapproved’ medicine containing these substances to patients under their care for these specific uses.

“We are delighted with the decision which will be welcomed by so many suffering Australians. The decision specifically recognises the current lack of options for patients with specific treatment resistant mental illnesses and the supporting evidence of safety and efficacy from clinical trials,” Chairman of Mind Medicine Australia, Peter Hunt AM said.

“While not yet a medicine registered on the Therapeutic Goods Register, this decision will enable appropriately screened patients with treatment resistant depression and treatment resistant post-traumatic stress disorder to access these medicinal therapies through authorised psychiatrists.”