DURECT Corporation Announces Second Quarter 2009...(Complete Response Letter from the ...),Health

Date:8/3/2009

Complete Response Letter from the FDA in December 2008 indicating that the NDA is not approved in its present form. King Pharmaceuticals, the commercialization partner of Pain Therapeutics for Remoxy, assumed responsibility for further development of Remoxy from Pain Therapeutics in March 2009 and met with the Food and Drug Administration (FDA) on July 2, 2009 to discuss the Complete Response Letter. According to King Pharmaceuticals and Pain Therapeutics, the outcome of that meeting provided King with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter. According to the King Pharmaceuticals / Pain Therapeutics press release, King now anticipates the resubmission of the NDA could occur mid-year 2010. King has stated that it remains committed to the development and commercialization of REMOXY and looks forward to working closely with the FDA toward approval of the product. REMOXY, an investigational drug, is a long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR(R) 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(TM) (SABER(TM)-Bupivacaine). During the quarter, DURECT continued enrollment in our approximately 60 patient Phase IIb clinical study in shoulder surgery. In addition, Nycomed continued enrollment in a Phase IIb study in hysterectomy patients and a Phase IIb study in shoulder surgery patients. We are in active discussions with multiple potential partners regarding licensing of the U.S./Canada and Asian rights to this program. POSIDUR is our investigational post-operative pain r
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