Creso Pharma Ltd (ASX:CPH, OTCQB:COPHF) is exploring opportunities to register its synthetic psilocybin formulation for the Australian market.
Following recent regulatory changes made by the Therapeutic Goods Administration (TGA), the doors are now open for wholly-owned psychedelics subsidiary Halucenex Life Sciences Inc. to bring its products down under.
The TGA announced last week, that from July 1, 2023, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.
The TGA will permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression. These are the only conditions where there is sufficient evidence for potential benefits in certain patients.
Essentially, the medical use of MDMA and psilocybin respectively will be rescheduled from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines).
PTSD trials continue
Halucenex is undertaking a Phase II clinical trial which will test the efficacy of psilocybin on treatment-resistant PTSD and has recruited 20 patients from the single–arm, open-lab trial that all suffer from the condition, as well as other mental illnesses including anxiety, suicidal thoughts, ADHD, depression and anger.
The company is confident that the data generated from this trial will provide a strong foundation for the registration of its Lucenex-branded synthetic psilocybin product, as a potential treatment route in Canada and Australia, pending further regulatory requirements. Halucenex is already a Licensed Psilocybin Supplier under Health Canada’s Special Access Program.
CPH is working with Australian-based research organisations and potential partners to progress these opportunities.
“This is a landmark moment for psychedelic therapy in Australia. The TGA’s decision provides considerable validation of Halucenex’s work to date and highlights the significant opportunity Creso Pharma has as an early-stage pioneer of medical psilocybin,” CPH CEO and managing director William Lay said.
“Halucenex’s clinical trial is advancing pleasingly. We are confident that data generated from the initiative will provide a much greater insight into how Lucenex can be used as a potential treatment route for debilitating health conditions.”