A number of people have reached out asking for Psylo’s view on the TGA’s decision not to reschedule psilocybin and MDMA, which are currently Schedule 9 drugs seen to have no medicinal benefit. A few comments on what it means for our company, and the psychedelic science arena at large.
This decision was disappointing, but not unexpected. The TGA is a relatively conservative regulatory body — until these substances are approved as medicines and rescheduled in the US and elsewhere, the TGA are unlikely to proactively reclassify them here in Australia.
Rescheduling is a matter of when not if. Psilocybin and MDMA have shown excellent safety and efficacy in dozens of clinical trials. It is likely that the FDA will approve these substances as medicines in the next several years, at which point they they will be rescheduled in the US — a move that will guide regulators around the world.
This decision does not impact Psylo. The announcement is obviously disappointing for many patients, researchers, and clinicians. However, Psylo is not impacted by this outcome. Our pipeline of next generation psychedelic-inspired molecules does not include Schedule 9 controlled substances. Indirectly, our preclinical R&D program is guided by the latest clinical evidence — and rescheduling would have improved clinical access to these substances.
We hope this helps to clarify our position. It is likely that the TGA will reschedule psilocybin and MDMA as these substances are approved as medicines in other parts of the world. Until then we’ll continue to develop psychedelic-inspired medicines to treat mental illness based on the blueprints these molecules offer.
