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DURECT Corporation Announces Second Quarter 2012 Financial Results and Update of Programs
Date:8/6/2012

CUPERTINO, Calif., Aug. 6, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2012. Total revenues were $4.8 million for the three months ended June 30, 2012 as compared to $7.8 million for the three months ended June 30, 2011.  Net loss for the three months ended June 30, 2012 was $4.3 million, compared to a net loss of $5.2 million for the same period in 2011.(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

At June 30, 2012, we had cash and investments of $23.7 million, compared to cash and investments of $26.4 million at March 31, 2012 and $30.8 million at December 31, 2011.  We have no debt obligations, other than normal liabilities associated with running our business."Based on our recent pre-NDA communications with the FDA, we intend to submit a new drug application for POSIDUR in late 2012 or early 2013," stated James E. Brown, D.V.M., President and CEO of DURECT.  "We are also pleased that Pfizer continues to move forward with their efforts to prepare for an FDA interaction later this year with respect to REMOXY and that Zogenix has commenced a Phase I clinical trial for Relday."

Update of Programs:

  • REMOXY® (oxycodone) Extended-Release Capsules CII.  Pfizer has efforts underway to resolve the issues raised in the REMOXY Complete Response Letter and stated in their earnings call on July 31, 2012 that they are analyzing preliminary results from two bioavailability studies and hoping to meet with the FDA in the fourth quarter.  The issues raised in the Complete Response Letter relate primarily to manufacturing.
    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
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    • SOURCE DURECT Corporation
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