Emyria (ASX:EMD) has announced that the first patients have been successfully dosed in its Phase 3 clinical trial for EMD-RX5.
EMD-RX5 is being developed as a potential over-the-counter (OTC) treatment for the symptoms of psychological distress.
The trial is being conducted across nine sites. It is designed to evaluate the safety and efficacy of EMD-RX5 in patients with symptoms of psychological distress such as mild anxiety and stress.
The trial is expected to enrol and dose 300 patients.
Emyria’s managing director Dr Michael Winlo said, “An accessible, convenient and effective over-the-counter treatment for psychological distress could have a significant impact on the quality of life and health outcomes for patients, especially those with chronic disease.
"We believe EMD-RX5 represents a significant commercial opportunity as it has been uniquely formulated to meet the registration requirements of multiple global markets,. The need for mental health treatments is large and growing, and an over-the-counter option could support a large segment of the population alongside prescription medication and non-drug therapy.”