In a decision released on 3 February 2023, the Australian Therapeutic Goods Administration (TGA) have agreed to amend the Poisons Standard to include new Schedule 8 entries for both psilocybine (i.e., psilocybin) and N,α-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) for the treatment of certain medical conditions. Following this change, which is scheduled for implementation on 1 July 2023, both psilocybine and MDMA will be available to patients outside of clinical trials, under the supervision of psychiatrists in medically controlled settings. This decision represents a significant departure to the TGA’s previous position on the therapeutic use of psilocybine and MDMA, which was based on the view that there was insufficient clinical data to justify re-scheduling.
As set out in the TGA’s final decision, which is available here, the TGA made reference to the results presented by Goodwin et al. in the New England Journal of Medicine as providing further weight to the existing body of evidence to support the use of psilocybine for treatment-resistant depression (TRD) and the designation of MDMA as a “breakthrough therapy” by the FDA as being determinative in the re-scheduling decision. Moreover, the TGA also considered the 6,650 and 6,505 public submissions to the psilocybine and MDMA proposals, respectively, to be an indicator of the scope and gravity of the public heath need that is addressed by the increased access to these substances for therapeutic purpose.
Perhaps unsurprisingly, the TGA has adopted a relatively conservative approach to the down-scheduling of psilocybine and MDMA, which is not dissimilar to the approach adopted to the down-scheduling of cannabis. For instance, psilocybine and MDMA will only be available to patients via a prescription from psychiatrists who are authorized under the Authorized Prescriber Scheme. In addition, the new Schedule 8 entries limit the use of psilocybine for the treatment of TRD and MDMA for the treatment of PTSD. However, as the body of clinical research supporting broader uses of psilocybine and MDMA for the treatment of other indications develops, we expect that the TGA will also broaden the permitted uses for these agents in the Poisons Standard. To this end, the TGA has also recognized that there are a number of Phase II and mixed Phase I/II clinical trials that are currently underway in Australia that are investigating the role of psilocybine and MDMA for the treatment of depression, anxiety disorders or post-traumatic stress disorder (PTSD), which is reflective of the level of academic interest in this space.
The decision by the TGA to down-schedule psilocybine and MDMA for therapeutic use in TRD and PTSD represents an important milestone in the acceptance of psychedelic therapy in Australia. Moreover, with Australia becoming a leader in clinical trials for investigation of psychedelic therapies, the down-scheduling of psilocybine and MDMA will likely increase clinical trial and research activity in this space, at least by streamlining the administrative process to obtain clinical trial approvals. Such activities will require significant financial investment to bring these psychedelic therapies to the market, which should be supported by intellectual property rights protection to ensure a return on that investment. If you have any questions about intellectual property rights for psychedelic therapies, such as psilocybine and MDMA, our experts at DCC and DCCL will be pleased to assist.
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