Pharmaceuticals company Emyria (ASX: EMD) is set to commence the regulatory process of registering their cannabinoid-based medicine EMD-003 as a treatment to reduce symptoms of mental health disorders, leveraging extensive data gathered from their network of clinics.
Initial evidence collected by Emyria’s subsidiary Emerald Clinics has identified an unmet need by targeting the treatment of psychological distress and the symptoms of anxiety, depression and stress within specific patient demographics. Drawing upon this data, Emyria will commence the registration study for EMD-003 with planned human trials to commence within the next six months.
“Since our doctors are focussed on getting the best outcome for every patient, we gain unique insights into the performance of a wide range of products and doses across a diverse range of patients and conditions,” said Emyria Managing Director, Dr Michael Winlo.
“By also taking our time with every patient and using our bespoke digital health platform, which also incorporates remote monitoring, we have built a high-quality and one-of-a-kind, clinical data asset.
“We’re excited to pursue the pivotal registration study of EMD-003 with the TGA in 2021 and help tackle the growing global concern of mental health and, in particular, the symptoms of anxiety, depression and stress.”
At present, there is only one cannabinoid-based medicine that has been formally registered with Australia’s Therapeutic Goods Administration, with all other products only available via Special Access Schemes, Authorised Prescribers, or clinical trials.
Mental health however, has been a major focus of cannabinoid-based medicine trials around the world. In a 2018-19 study, it was identified that 4.3 million Australians received mental health related prescriptions including over 27 million antidepressant prescriptions.
In the coming months, more cannabinoid-based products will be made available to Australians following the de-scheduling of cannabinoids last month by the TGA which will enable low-dose products to be purchased over-the-counter without a prescription.