Bioxyne granted Australia’s first GMP licence for Psilocybin and MDMA manufacturing

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Bioxyne Limited’s subsidiary, Breathe Life Sciences (BLS), has secured the Good Manufacturing Practice (GMP) licence for the production of medical cannabis.

The ASX-listed company said this landmark licence extends to the manufacturing of Psilocybin and MDMA, marking a significant milestone as the first GMP certification for these substances in Australia.

The Therapeutic Goods Administration (TGA) has granted BLS the GMP licence, encompassing parts 1 and 2, enabling the company to manufacture MDMA and Psilocybin active pharmaceutical ingredients (APIs) and final dose capsules.

These products are intended for supply to authorised prescribers and clinical trials, opening new avenues for the treatment of mental health disorders.

Bioxyne’s entry into medical cannabis manufacturing, initiated in 2022, has seen rapid progress, establishing a robust brand and distribution network within Australia.

This latest licence is the most comprehensive to date, showcasing Bioxyne’s leadership in innovative therapeutic solutions.

With TGA’s authorisation since July 2023, prescribers can now prescribe MDMA and Psilocybin outside of clinical trials.

MDMA has shown promising outcomes in treating PTSD, while Psilocybin has demonstrated significant, sustained reductions in depressive symptoms following therapy sessions.

CEO of Bioxyne, Sam Watson, expressed his enthusiasm for the achievement, stating, “This licence is a testament to our commitment to responsibly manufacturing alternative medicines that offer new hope for those battling mental health conditions resistant to conventional treatments.”

Macdarragh O’Neill, head of GMP Production, added, “Achieving this GMP licence is a monumental step for both Breathe Life Sciences and Bioxyne. It’s the culmination of three years of dedicated effort and positions us to scale our operations significantly, both in Australia and internationally.”

Bioxyne said it aims to become the premier supplier of Psilocybin and MDMA for clinical trials and authorised prescribers by 2025.

The company is actively pursuing partnerships with veteran groups, universities, trial sponsors, and authorised prescribers in Australia and globally.