EmpowerPharm Inc. Receives FDA Clearance of its Investigational New Drug (IND) Application for a Phase II Clinical Trial of Empower CBD™ for the Treatment of Social Anxiety Disorder

EmpowerPharm Inc a clinical-stage life sciences company focused on research and clinical development announced today May 13th, 2022 that the U.S. Food and Drug Administration (FDA) has provided clearance to proceed with the Company’s Investigational New Drug (IND) application to commence a Phase II clinical study. EmpowerPharm is the sponsor of EPI-CBD-001, a Phase II clinical trial, which is a randomized, double blind, parallel group, placebo-controlled study evaluating the efficacy, safety and tolerability of cannabidiol in patients with Social Anxiety Disorder. 

EmpowerPharm’s Phase II study is expected to enroll 225 patients at 22 clinical centers in the United States.   

The study has been designed by an independent committee comprising distinguished leaders in mental health. 

“IND clearance to proceed with our Phase II clinical trial of Empower CBDTM in patients with social anxiety disorder represents another major milestone for EmpowerPharm as we continue to pursue the development of new treatment options for patients suffering from social anxiety disorder,” said Peter Billiaert, President and Co-Chief Executive Officer of EmpowerPharm Inc.