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DURECT Reports Data From European Phase IIb Hysterectomy Study of POSIDUR(TM) (SABER(TM)-Bupivacaine)
Date:6/16/2010

CUPERTINO, Calif., June 16 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today results from a European Phase IIb hysterectomy clinical trial conducted by Nycomed of POSIDUR™ (also known as SABER™-bupivacaine or Optesia™ in the E.U.), a proprietary product under development for the treatment of post-surgical pain.

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This hysterectomy trial is part of Nycomed's clinical development program for Europe for POSIDUR.  In this study, 115 patients were randomly assigned to one of three treatment groups prior to undergoing open hysterectomy surgery: POSIDUR at a dose of 5 mL, an active comparator (commercially available bupivacaine HCI solution) or SABER-Placebo (SABER vehicle without drug).  All patients were given a background pain treatment consisting of a daily dose of two or four grams (depending on the patient's weight) of paracetamol (acetaminophen).  In addition, each patient was provided supplemental opioid rescue medication, if needed.

With respect to efficacy, the primary endpoints of the study were to show (1) non-inferiority of POSIDUR to SABER-Plac
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SOURCE DURECT Corporation
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