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DURECT Corporation Announces Second Quarter 2013 Financial Results and Update of Programs
Date:8/5/2013

CUPERTINO, Calif., Aug. 5, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the second quarter of 2013. Total revenues were $3.9 million for the three months ended June 30, 2013 as compared to $4.8 million for the three months ended June 30, 2012.  Net loss for the three months ended June 30, 2013 was $5.1 million, compared to a net loss of $4.3 million for the same period in 2012. 

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At June 30, 2013, we had cash and investments of $21.3 million, compared to cash and investments of $25.5 million at March 31, 2013 and $28.9 million at December 31, 2012."We are pleased that our New Drug Application (NDA) for POSIDUR has been accepted by the FDA and the PDUFA date is approximately 6 months away," stated James E. Brown, D.V.M., President and CEO of DURECT.  "Another recent positive event was the selection of a lead formulation in our ORADUR-ADHD program, enabling us to commence a proactive business development effort for that program."

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. 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.
    POSIDUR is our investigational post-operative pain relief depot that utilizes our patented SABER technology to deliver bupivacaine to provide up to th
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  • SOURCE DURECT Corporation
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