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DURECT Corporation Announces Third Quarter 2012 Financial Results and Update of Programs
Date:11/5/2012

CUPERTINO, Calif., Nov. 5, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended September 30, 2012. Total revenues were $3.8 million for the three months ended September 30, 2012 as compared to $8.1 million for the three months ended September 30, 2011.  Net loss for the three months ended September 30, 2012 was $4.8 million, compared to a net loss of $5.0 million for the same period in 2011.

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At September 30, 2012, we had cash and investments of $21.0 million, compared to cash and investments of $23.7 million at June 30, 2012 and $30.8 million at December 31, 2011.  We have no debt obligations, other than normal liabilities associated with running our business."Following our pre-NDA communications with the FDA this summer, we are preparing to submit a new drug application for POSIDUR in the first quarter of 2013," stated James E. Brown, D.V.M., President and CEO of DURECT.  "Pfizer has initiated a confirmatory bioavailability study to assess the pharmacokinetic profile of modified REMOXY formulation compositions, with a data read out expected early in 2013.  We also are pleased that Zogenix has been actively enrolling in the 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 quarterly earnings call on November 1, 2012 that they have initiated a confirmatory bioavailability study to assess the pharmacokinetic profile of modified REMOXY formulation compositions, with data expected in early 2013.  Pfizer expects that the results of this study wi
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