Australia has become the first country in the world to officially recognise psychedelics as medicines, which is good news for Creso Pharma.

Creso Pharma (ASX:CPH) has announced its wholly owned subsidiary, Halucenex Life Sciences Inc will pursue Australian market entry following a landmark decision by the  Therapeutic Goods Administration (TGA).

The TGA approved psychedelic substances used in magic mushrooms and MDMA, making Australia the first country in the world to recognise psychedelics as medicine.

From July 1 this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions.

Halucenex in phase II trial for PTSD

Among mental health conditions the TGA listed for treatment using the psychedelic substances is post-traumatic stress disorder (PTSD).

Halucenex is currently advancing a phase II clinical trial to test the efficacy of psilocybin on treatment resistant PTSD which is expected to complete in H1 2023.

There are currently 20 recruited patients in the single–arm, open-lab trial that all suffer from the condition, as well as other mental illnesses such as (but not limited to) anxiety, suicidal thoughts, ADHD, depression, and anger.

Real world data generated from the ongoing trial may form the basis of Halucenex’s Australian market strategy.

Licenced psilocybin supplier in Canada

Halucenex is already a licensed psilocybin supplier under Health Canada’s Special Access Program and is well advanced in psychedelic assisted therapy R&D.

CPH is confident data generated from the phase II 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.

As the new Australian regulations come into effect close to the expected completion date of the trial, CPH intends to explore opportunities for registration of its synthetic psilocybin in the country.

CEO and managing director William Lay said the TGA’s approval was 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,” he said.

“Halucenex’s clinical trial is advancing well, and we are confident that data generated will provide a much greater insight into how Lucenex can be used as a potential treatment route for debilitating health conditions.”

Creso recently released its FY22 results including unaudited revenue of ~$9 million , a record year and marking a 44% increase on FY2021 as it works to become profitable.

This article was developed in collaboration with Creso Pharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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