ClinicalDevelopment
CLINICAL PROGRAM UNDER WAY TO TRANSFORM ANECDOTES INTO SCIENCE
- EmpowerPharm is the sponsor of EPI-CBD-001, a Phase II clinical trial – a multicenter, randomized, double blind, parallel group, placebo-controlled study evaluating the efficacy, safety and tolerability of cannabidiol oral solution at two dose-strengths in patients with Social Anxiety Disorder
- US FDA Investigational New Drug (IND) application approval was received prior to the start of the study
- Syneos is the Clinical Research Organization (CRO) that manages the study with 239 randomized patients, out of which 178 completed the study, at 19 clinical sites in the USA.
- Successful Phase II results will lead to a Phase III trial using EmpowerCBD™ solid oral dose formulation
- Successful completion of the clinical program will lead to the filing of a New Drug Application (NDA) in the US and New Drug Submission (NDS) in Canada
- Additional information of the Phase II clinical study can be found in www.clinicaltrials.gov; study identifier NCT05600114