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DURECT Corporation Announces First Quarter 2011 Financial Results and Update of Programs
Date:5/5/2011

ely 300 patients, in the third quarter of 2011 with top-line data anticipated in the fourth quarter of 2011.  Based on a pooled and blinded analysis of the variability of data within BESST, we do not plan to increase the size of the study.

In February 2011, we announced results from a shoulder surgery Phase II study conducted in Europe by Nycomed.
At that time, we and Nycomed amended our agreement such that, for an interim period, 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 E.U. and the U.S.

POSIDUR is our post-operative pain relief depot that utilizes our patented SABER technology to deliver bupivacaine to provide up to three days of pain relief after surgery. POSIDUR is licensed to Hospira for commercialization in the U.S. and Canada, and to Nycomed for commercialization in Europe and other defined countries. We have retained commercialization rights in Japan and all other countries not subject to the Nycomed and Hospira licenses.

  • ELADUR (TRANSDUR®-Bupivacaine).  Pfizer completed its acquisition of King in February 2011 and as a result has assumed the development and commercialization rights and obligations to ELADUR.  In April 2011, we announced top-line results from a Phase II clinical trial conducted by King for the treatment of chronic low back pain.  The primary efficacy endpoint for the trial was not met.  Complete data analysis is on-going.  We and Pfizer are continuing to analyze these data and will work together to determine next steps for ELADUR.

  • ELADUR is our proprietary transdermal patc
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