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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

ically relevant trend in opioid sparing for POSIDUR compared to SABER-placebo and the pre-specified sensitivity analysis showed a statistically significant difference in opioid sparing in favor of POSIDUR.  No statistical differences were found when POSIDUR was compared to the active comparator arm.  

Overall, there was a comparable safety profile between the three groups in this study and POSIDUR appeared well tolerated.  

Nycomed is currently finalizing the Phase IIb shoulder study clinical trial report and will be evaluating the E.U. program for POSIDUR pending a review of data from the U.S. Phase III trial (BESST) which involves three abdominal surgical models.  Until results are received from BESST, the parties have amended their agreement such that DURECT will have full control and financial responsibility for non-clinical and CMC activities which had been previously jointly controlled and funded by DURECT and Nycomed.  If Nycomed elects to continue European development of POSIDUR after evaluation of BESST data, under the terms of the amendment, DURECT and Nycomed would resume joint control and financial responsibility of the non-clinical and CMC activities for the EU and the U.S.  

"We are pleased to have data from an orthopedic model which showed that patients treated with POSIDUR had better pain control and consumed fewer opioids compared with patients on placebo while also showing a good safety profile," stated James E. Brown, President and CEO of DURECT. "The purpose of the amendment is to provide Nycomed with the opportunity to review the European program with BESST data in hand while in the meantime we and Hospira (our collaborator in the U.S. and Canada) continue to drive forward and control the CMC and non-clinical development activities in anticipation of preparing our U.S. NDA submission.  We are currently enrolling in BESST, our U.S. pivotal Phase III study and anticipate completing enrollmen
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SOURCE DURECT Corporation
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