CUPERTINO, Calif., Jan. 19 /PRNewswire-FirstCall/ -- DURECT Corporation announced today that it has begun dosing patients in its U.S. pivotal Phase III clinical trial to evaluate POSIDUR(TM) (SABER(TM)-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.”
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 approximately 300 patients undergoing a variety of general abdominal surgical procedures. Eligible patients will be randomly assigned to one of three cohorts:
Cohort 2: An active comparator cohort in which patients are randomized to receive either POSIDUR 5.0 mL or commercially available Bupivacaine HCl solution after laparoscopic cholecystectomy.
Efficacy evaluation in the BESST trial will encompass a number of parameters. The two co-primary efficacy endpoints for Cohort 3 will be mean pain intensity on movement (normalized) Area Under the Curve (AUC) during the period 0-72 hours post-dose and mean total morphine equivalent opioid dose for supplemental analgesia during the period 0-72 hours post-dose. An adaptive feature of BESST allows for upsizing of the patient sample size in Cohort 3 based on pooled and blinded data. The purpose of Cohorts 1 and 2 is to give us additional experience with the use of POSIDUR in a broader group of surgeries and patients.
In November 2006, DURECT signed a collaboration agreement with Nycomed, a privately-held European pharmaceutical company headquartered in Switzerland, whereby DURECT has licensed Nycomed the exclusive commercialization rights to POSIDUR in the European Union (E.U.) and select other countries. In addition, under the agreement, DURECT will manufacture and supply the product to Nycomed for commercial sale in the territory licensed to Nycomed. DURECT retains full ownership of POSIDUR in the U.S., Canada, Asia and other countries.
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About DURECT Corporation
NOTE: POSIDUR(TM), SABER(TM), ORADUR(R), TRANSDUR(TM), and ELADUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
CONTACT: Matthew J. Hogan, Chief Financial Officer of DURECT Corporation,
+1-408-777-4936
Web site: http://www.durect.com/
