Sept. 6, 2011
/PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today the dosing of the last patient in the U.S. pivotal Phase III clinical study for POSIDUR® known as BESST (Bupivacaine Effectiveness and Safety in SABER trial). POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER™ technology to deliver bupivacaine to provide up to three days of pain relief after surgery. DURECT expects to report top-line data from the BESST trial in the fourth quarter of 2011 and, if the data are positive, to submit the New Drug Application in the first half of 2012.
"We believe that POSIDUR has the potential to play a major role in treating post-surgical pain, reducing the need for systemic narcotics and associated side effects, as well as costs associated with extended hospital stays," stated
James E. Brown
, President and CEO.
"We are encouraged by this important development milestone for POSIDUR, an innovative product candidate which may represent a significant step-forward in the management of acute pain for patients following surgical procedures. Hospira is committed to bringing POSIDUR to market rapidly following FDA review and approval," added
, Vice President, corporate development at Hospira, Inc.
POSIDUR is licensed to Hospira (NYSE: HSP) for commercialization in the U.S. and
About the Design of BESST
BESST is an international, multi-center, randomized, double-blind, controlled trial evaluating the safety, efficacy, effectiveness, and pharmacokinetics of POSIDUR in 305 patients undergoing a variety of general abdominal surgical procedures. Eligible patients were randomly assigned to one of three cohorts:
Cohort 1: An active comparator cohort in which 48 patients were randomized to receive either POSIDUR 5.0 mL or commercially available Bupivacaine HCl solution after laparotomy.