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DURECT Corporation Announces Second Quarter 2011 Financial Results and Update of Programs
Date:8/4/2011

ssues described in the Complete Response Letter, has efforts underway to resolve these issues and plans to have further discussions with the FDA about them.  Resolution of these issues and potential regulatory approval of REMOXY in the U.S. is unlikely to occur in less than one year, and could be delayed significantly longer than a year. REMOXY, an investigational drug, is a unique long-acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR® technology, which is covered by issued patents and pending patent applications owned by us, REMOXY is designed to resist common methods of prescription drug misuse and abuse.  


  • POSIDUR (SABER™-Bupivacaine) Post-Operative Pain Relief Depot. During the second quarter of 2011, patient enrollment continued in our U.S. pivotal Phase III clinical study known as BESST (Bupivacaine Effectiveness and Safety in SABER Trial).  As of August 3, we had dosed 293 patients out of our target of 304.  At our current enrollment rate, we expect to complete enrollment in approximately a month.  We continue to anticipate reporting top-line data in the fourth quarter of 2011.  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 Pharmaceuticals (King) in February 2011 and as a result has assumed the development and commercialization rights and obligations to ELADUR.  In April 2011, we announced
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