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DURECT Corporation Announces Second Quarter 2011 Financial Results and Update of Programs
Date:8/4/2011

CUPERTINO, Calif., Aug. 4, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2011. Total revenues increased to $7.8 million for the three months ended June 30, 2011 from $7.3 million for the three months ended June 30, 2010.  Net loss for the three months ended June 30, 2011 was $5.2 million, compared to a net loss of $6.3 million for the same period in 2010.(Logo:  http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

At June 30, 2011, we had cash and investments of $37.5 million, compared to cash and investments of $41.9 million at March 31, 2011 and $49.6 million at December 31, 2010.  We have no debt obligations, other than normal liabilities associated with running our business.

"We are supporting Pfizer in resolving the remaining issues related to REMOXY® and appreciate the experienced team Pfizer has dedicated to these efforts," stated James E. Brown, D.V.M., President and CEO of DURECT.  "We are 11 patients away from completing enrollment in our pivotal Phase III trial for POSIDUR™ (BESST), and we expect to have top-line data in the fourth quarter of this year.  In July, as a culmination of a multi-year feasibility effort between Zogenix and us, we added a new antipsychotic development program to our pipeline."

Update of Programs:

  • REMOXY.  On June 23, 2011, Pfizer received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the REMOXY New Drug Application (NDA) which had been resubmitted in December 2010.  The FDA's Complete Response Letter raised concerns related to, among other matters, the Chemistry, Manufacturing, and Controls (CMC) section of the NDA for REMOXY.  Pfizer is working to evaluate the i
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