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DURECT Corporation Announces Third Quarter 2013 Financial Results and Update of Programs
Date:11/4/2013

CUPERTINO, Calif., Nov. 4, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the third quarter of 2013. Total revenues were $3.0 million for the three months ended September 30, 2013 as compared to $3.8 million for the three months ended September 30, 2012.  Net loss for the three months ended September 30, 2013 was $6.0 million, compared to a net loss of $4.8 million for the same period in 2012. 

(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

At September 30, 2013, we had cash and investments of $17.4 million, compared to cash and investments of $21.3 million at June 30, 2013 and $28.9 million at December 31, 2012."We are pleased that the mid-cycle review by the FDA of the New Drug Application (NDA) for POSIDUR™  is behind us and the PDUFA date is now just a little over 3 months away," stated James E. Brown, D.V.M., President and CEO of DURECT.  "We are also pleased that, after achieving technical milestones and after a thorough program review, Pfizer is proceeding with the development of REMOXY® with no changes to the previously described timelines." 

Update of Programs:

  • POSIDUR (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. In April 2013, we submitted a new drug application (NDA) as a 505(b)(2) application, which relies in part on the FDA's findings of safety and effectiveness of a reference drug. In June 2013, we announced that our NDA submission had been accepted by the FDA, indicating that the application is sufficiently complete to permit a substantive review. At this point, we are past the mid-cycle review by the FDA and the Prescription Drug User Fee Act (PDUFA) goal date (the date the FDA expects to complete its review of the NDA) is February 12, 2014
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