Positive results from DURECT's Phase IIb POSIDUR clinical trial for post-surgical pain

DURECT Corporation (Nasdaq: DRRX) announced today positive results from a 60 patient Phase IIb clinical trial of POSIDUR(TM), a proprietary product under development for the treatment of post-surgical pain. Top line results from this study of patients undergoing arthroscopic shoulder surgery showed a consistent reduction of pain scores (as measured by mean pain intensity on movement AUC, time normalized under the curve, during the period 0 to 72 hours post-surgery) in parallel with a reduction of opioid use (as measured by the amount of opioids taken in the three days post-surgery) in favor of POSIDUR versus placebo. These reductions were not statistically significant given the size of the study. In addition, there was a comparable safety profile between the two groups in this study and POSIDUR appeared well tolerated.

"We are pleased that this study provides a consistent signal of the analgesic effectiveness of POSIDUR in an orthopedic surgical model," stated James E. Brown, President and CEO of DURECT Corporation. "We look forward to commencing enrollment of the U.S. Phase III program in the first quarter of 2010."

The POSIDUR Phase IIb clinical trial was a double blind, multi-center, placebo controlled, parallel group trial in patients undergoing arthroscopic shoulder surgery. Eligible patients were randomly assigned to one of two treatment groups prior to surgery (SABER(TM)-Bupivicaine (POSIDUR) or SABER-Placebo). Supplemental rescue analgesia for post-operative shoulder pain in both treatment groups was provided if needed. The study was conducted at sites in Australia and New Zealand.