Formulytica poised to develop clinical-ready formulations of psilocybin and MDMA

Formulytica poised to develop clinical-ready formulations of psilocybin and MDMA

Formulytica is pleased to announce that it has been granted a licence from the Victorian Department of Health enabling it to develop new clinical-ready pharmaceutical formulations containing the drugs psilocybin and MDMA (3,4-methylenedioxy-methamphetamine). This news comes following the recent decision by the Therapeutic Goods Administration (TGA) in Australia to change the classification of psilocybin and MDMA, allowing authorised psychiatrists to prescribe them under the Authorised Prescriber Scheme for certain mental illnesses.

From 1 July 2023, Psilocybin and MDMA will be classified as Schedule 8 poisons when prescribed by authorised psychiatrists for certain medical conditions. Previously, they were classified as Schedule 9 poisons, meaning they were prohibited from use except for research or analytical purposes.

The change in classification is based on growing evidence that psilocybin and MDMA may have therapeutic benefits for a range of mental health conditions, including treatment-resistant depression and post-traumatic stress disorder. Formulytica is excited about the potential for these drugs to improve the lives of people suffering from these conditions, and is committed to developing safe and effective formulations to support their use.

Formulytica specialises in developing innovative drug formulations and analytical methods that are essential for any new medicine entering clinical trials. Our team has a deep understanding of the importance of developing robust formulations and analytical methods to ensure the safety, efficacy, and quality of drug products. With our expertise in developing a wide variety of dosage forms, including topical, oral, and injectable, and our expertise in analytical method development and stability testing, we are well-positioned to support the development of new clinical-ready formulations of psilocybin and MDMA.

For more information about the scheduling of poisons in Australia, please refer to the TGA’s website. For enquiries, contact us here.