In 2011, we look forward to:
Highlights for DURECT in Fiscal Year 2010 and Major Potential Milestones over the Next 12-18 Months:
REMOXY. We are looking forward to the anticipated June 23, 2011 PDUFA goal date. In December 2010, King resubmitted the New Drug Application (NDA) for REMOXY to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter received by Pain Therapeutics in December 2008. In July 2009, King met with the FDA to discuss the Complete Response Letter. Pfizer completed its acquisition of King in February 2011 and as a result has assumed the development and commercialization rights and obligations to REMOXY and to the three other licensed ORADUR-based opioid drug candidates (hydrocodone, hydromorphone and oxymorphone). 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. In 2010 and early 2011, Nycomed completed two Phase II studies in Europe, one in hysterectomy and another in shoulder surgery. In February 2011, we and Nycomed amended our agreement such that DURECT will have full control and financial resp
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