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DURECT Reports Data From European Phase IIb Shoulder Study of POSIDUR™ (SABER™-Bupivacaine) and Amendment of the Nycomed Agreement
Date:2/9/2011

CUPERTINO, Calif., Feb. 9, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today results from a European Phase IIb shoulder 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, and the amendment of the Company's collaboration agreement with Nycomed.

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This shoulder trial is part of Nycomed's clinical development program for Europe for POSIDUR.  In this study, 107 patients were randomly assigned to one of three treatment groups prior to undergoing elective arthroscopic shoulder 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.

The primary efficacy endpoints of this Phase IIb study were to demonstrate: (1) non-inferiority of POSIDUR to SABER-Placebo (with all groups taking the background and supplemental pain treatment as described above) in terms of pain intensity on movement area under the curve (AUC) during the period 1-72 hours post-surgery, and (2) superiority of POSIDUR against SABER-Placebo in the total use of opioid rescue analgesia 0-72 hours post-surgery.  Top-line results from this study demonstrate that the POSIDUR group experienced a statistically significant reduction in pain intensity versus SABER-Placebo. The results of the pre-specified primary analysis indicated a clear clin
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