The Therapeutic Goods Administration (TGA) has rejected moves to down-schedule MDMA and psilocybin from a prohibited schedule 9 drug to a controlled schedule 8 drug for use in mental health treatment.
The decision was met with dismay by Mind Medicine Australia who said it will leave many sufferers in “despair”.
The application to amend the Poisons Standard and allow the drugs to be used alongside psychotherapy for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD) was turned down following an independent review published in October.
The Delegate’s final decision, confirming its interim ruling, states: “I am of the view that although findings from clinical trials are promising for TRD, further evidence is required to establish therapeutic value and outweigh the risks from misuse or diversion for illicit use across the supply chain that may arise from any down-scheduling.
“I note that my decision does not affect current access to psilocybin for use in a clinical trial setting under schedule 9.
“The outcomes of further clinical trials could result in there being more supportive evidence in the future. Down-scheduling could be further considered if there were more evidence of therapeutic value from such clinical trials.
“There are still provisions for clinical trials by approval of commonwealth and/or state or territory health authorities, with the potential to obtain further evidence which could inform future application for the down-scheduling of psilocybin.”
Mind Medicine Australia chairman Peter Hunt expressed the organisation’s dismay at the decision.
He said: “We are bitterly disappointed by the TGA’s decision because, in our view, the medical use of both psilocybin and MDMA within controlled medical environments by trained professionals should come squarely within Schedule 8 of the Poisons Standard.
“This is a view echoed by the many researchers and medical practitioners who supported our rescheduling applications.
“There are so many people suffering from treatment-resistant depression and treatment-resistant PTSD in Australia who will be in despair because of this decision. This leaves little hope for them.”