EmpowerPharm Inc. is delighted to announce the outcome of their Phase 2 clinical trial assessing the dose finding, efficacy, safety, and tolerability of Cannabidiol (CBD) drug product for Social Anxiety Disorder (SAD). The results demonstrated efficacy for a subset of patients suffering from moderate to severe SAD. These results will guide further clinical research and the design of a robust Phase 3 program.
The trial, sponsored by EmpowerPharm® was managed by Syneos Health. The study enrolled 239 patients from 19 clinical centers across the United States, 178 patients completed the study. It was a randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of 300mg and 600mg daily dosing of CBD in patients with Social Anxiety Disorder. It is the first, well powered and appropriately designed clinical trial to demonstrate efficacy, safety, and tolerability of CBD for the treatment of patients with chronic SAD.
The trial provided information about the likely effective dose that we will carry forward into a Phase 3 trial for the treatment of patients with chronic social anxiety symptoms using the Liebowitz Social Anxiety Scale (LSAS) as a measure of efficacy. In addition, the study demonstrated a favorable safety profile and excellent tolerability of CBD in this patient population.
The Liebowitz Social Anxiety Scale is a widely used questionnaire designed to assess the severity of social anxiety disorder. It consists of two subscales: one measuring fear (of social and performance situations) and the other measuring avoidance (of social and performance situations). The LSAS is used by clinicians and researchers to evaluate the extent and impact of social anxiety symptoms in individuals.
Peter Billiaert, President & Co-CEO said "I would like to acknowledge the tireless efforts of the scientific team, collaborators, and study participants, emphasizing the demand for new social anxiety disorder treatments. Looking ahead, the results of the Phase 2 study will guide further clinical research and the design of a robust Phase 3 program to advance the treatment of Social Anxiety Disorder". Billiaert continued, "EmpowerPharm® remains committed to providing safe and efficacious treatment alternatives for patients in need."