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

CUPERTINO, Calif., May 5, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2011. Total revenues increased to $8.6 million for the three months ended March 31, 2011 from $7.7 million for the three months ended March 31, 2010.  Net loss for the three months ended March 31, 2011 was $6.4 million, compared to a net loss of $6.6 million for the same period in 2010.(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

At March 31, 2011, we had cash and investments of $41.9 million, compared to cash and investments of $49.6 million at December 31, 2010."We are pleased that an experienced and professional organization such as Pfizer is handling the REMOXY® NDA resubmission, and if approved, the marketing of REMOXY," stated James E. Brown, D.V.M., President and CEO of DURECT.  "In addition, our pivotal Phase III trial for POSIDUR™ (BESST) is approaching completion of enrollment with top-line data anticipated this year.  These two most advanced programs are complemented by a diverse pipeline of other product candidates which we are progressing in the pain and ADHD markets."

Update of Programs:

  • REMOXY.  The U.S. Food and Drug Administration (FDA) has set a June 23, 2011 PDUFA goal date for the REMOXY New Drug Application (NDA) which was resubmitted in December 2010 by King Pharmaceuticals (King) following a Complete Response Letter received by Pain Therapeutics in December 2008.  Pfizer completed its acquisition of King in February 2011.  During Pfizer's first quarter earnings call on May 3, Pfizer stated that it was working to address a specific issue in the manufacturing section of the REMOXY application, as well as to understand any potential implications of FDA's rece
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  • SOURCE DURECT Corporation
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