Emyria will apply to register EMD-003, its cannabinoid-based medicine developed to reduce symptoms of anxiety, depression and stress, with the Therapeutic Goods Administration (TGA) in 2021.
EMD-003 is the first medicine Emyria has developed following extensive analysis of data gathered from clinical subsidiary Emerald Clinics.
Initial clinical evidence analysis and patent filing has been completed with clinical trials expected to begin in H1, 2021. Emyria aims to have a final evidence package to support registration ready in H2.
In parallel to the TGA registration plan, the company will design its EMD-003 studies to meet the requirements of other global regulatory bodies and enable it to subsequently apply for pharmaceutical registration in other major markets.
Emyria managing director Dr Michael Winlo said: “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.”