Emyria Limited announced that the first patients have been successfully dosed in its Phase 3 clinical trial for EMD-RX5. This marks an important milestone in the development of EMD-RX5 as the first potential over-the-counter (OTC) treatment for the symptoms of psychological distress. The trial, which is being conducted nationwide across 9 trial sites, 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 in H1, 2023 and, pending clinically significant results, will support a submission to the TGA. A multi-site, parallel-arm, randomised, double blind, placebo-controlled study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pain. 300 participants aged 18-70 with symptoms of stress and a background of chronic pain will be randomised to one month of treatment with either 50mg EMD-RX5, 150mg EMD-RX5 or matching placebo.

To determine the effect of EMD-RX5 treatment on symptoms of psychological distress in participants with chronic pain through change in self-reported DASS-21 score from baseline to Week 4.