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DURECT Corporation Announces First Quarter 2013 Financial Results and Update of Programs
Date:5/2/2013

otify us whether our NDA submission has been accepted for filing in June 2013.  If accepted for filing, the FDA would be expected to assign a Prescription Drug User Fee Act (PDUFA) target date (the date the FDA expects to complete its review of the POSIDUR NDA) in the first quarter of 2014.
DURECT will be presenting a poster on POSIDUR at the American Pain Society Meeting on May 9 from 9:30 to 11:00 a.m. in New Orleans.  This poster will summarize results from a well controlled shoulder surgery trial.  After the meeting, DURECT will make the poster available through our website www.durect.com.
POSIDUR is our investigational post-operative pain relief depot that utilizes our patented SABER technology to deliver bupivacaine to provide up to three days of pain relief after surgery.  We are in discussions with potential partners regarding licensing development and commercialization rights to POSIDUR, for which we hold worldwide rights.  
  • Transdermal Development Candidates.
    DURECT has two transdermal products that are in mid- to late-stage development with features that may be superior to currently available patches.  TRANSDUR®-Sufentanil is our proprietary transdermal patch intended to deliver sufentanil to chronic pain sufferers for a period of up to 7 days from a single application; this compares favorably against existing fentanyl patches which are substantially larger and typically effective for 2-3 days.  ELADUR®, for topical neuropathic conditions such as post-herpetic neuralgia (PHN), is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days from a single application; existing lidocaine patches for this condition can be worn for 12 hours with a rest period of 12 hours during which time many patients experience breakthrough pain.  We are in discussions with potential partners regarding licens
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