Published on January 19, 2010 at 11:22 PM
DURECT Corporation (Nasdaq: DRRX) announced today that it has begun dosing patients in its U.S. pivotal Phase III clinical trial to evaluate POSIDUR™ (SABER™-Bupivacaine), an investigational drug, for the treatment of post-surgical pain. The pivotal trial, referred to as BESST (Bupivacaine Effectiveness and Safety in SABER Trial), is an international, multi-center, randomized, double-blind, controlled trial evaluating the safety, efficacy, effectiveness, and pharmacokinetics of POSIDUR in patients undergoing general surgical procedures. We expect to enroll approximately 300 patients at approximately 20 clinical trial sites in the study.
"Initiation of our Phase III BESST program represents a significant milestone for DURECT," stated James E. Brown, President and CEO of DURECT Corporation. "We believe that POSIDUR, if approved, could improve the treatment of patients' post-surgical pain and reduce the use of opioids in this setting."
"BESST was designed based on feedback from the FDA as well as input from expert consultants and key opinion leaders," stated Joe Stauffer, Chief Medical Officer of DURECT Corporation. "We anticipate completing enrollment in the first half of 2011."
SOURCE DURECT Corporation