Good news from the Australian Therapeutic Goods Administration, as they will now allow for the prescription of MDMA to treat post-traumatic stress disorder (PTSD), and psilocybin to combat treatment-resistant depression. This new classification is a step forward in providing relief with alternative treatments that have been proven effective.
This ruling has established a worldwide benchmark for treatment with substances like MDMA and psilocybin.
Beginning July 1st, 2023, the substances that are currently in Schedule 9 of the Poisons Standard – known as prohibited substances – will be relocated to Schedule 8 and classified under controlled drugs.
Select mental health conditions can be treated with prescribed medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine). This is only available through authorised psychiatrists.
The Therapeutic Goods Administration (TGA) has officially granted permission for the use of MDMA and psilocybin as treatment options for those with post-traumatic stress disorder or treatment-resistant depression. Both medications have been deemed beneficial to certain patients due to accumulated evidence that suggests their effectiveness in treating these conditions. It is currently the only instance where such authorization exists.
Seeing the absence of choices for people suffering from hard-to-treat psychological illnesses, the TGA has affirmed that these two conditions are in fact the only ones with adequate evidence to have possible advantages on certain patients.
So, what now?
The ability to prescribe medication for serious mental health conditions will be exclusive to psychiatrists due to their specialized qualifications and experience. To gain prescribing approval, a psychiatrist must first receive approval from the Therapeutic Goods Administration under the Authorized Prescriber Scheme after being approved by an official Human Research Ethics Committee. This scheme is put in place with strict protocols that guarantee patient safety at all times.
Furthermore, researchers are able to use them in clinical trials of these conditions as they are classified as Schedule 9 substances. However, without proper authorization, the possession of such drugs under Schedule 8 will be considered illegal (e.g., possessing it outside a valid prescription).
Will psilocybin and MDMA be allowed to be prescribed for the treatment of other mental illnesses?
After careful consideration, the Delegate concluded that psilocybin and MDMA should only be proscribed as a Schedule 8 drug for those suffering from treatment-resistant depression or post-traumatic stress disorder since there is sufficient evidence to demonstrate how these substances could potentially benefit individuals with such conditions.
Should any new evidence come to light that indicates these substances could be beneficial in treating other conditions, the TGA will assess applications and may modify the Poisons Standard accordingly – which would consequently expand prescribing of psilocybin and MDMA for additional ailments.
For the time being, psilocybin and MDMA will still be restricted to clinical trials and medical research as outlined in Schedule 9 of the Poisons Standard. Under this classification, these substances must not be used for any other purposes than treating Treatment-resistant Depression (TRD) or Post Traumatic Stress Disorder (PTSD).
