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DURECT Corporation Announces First Quarter 2012 Financial Results and Update of Programs
Date:5/3/2012

as an issued European patent providing coverage to at least 2023."

Update of Programs:

  • REMOXY (oxycodone) Extended-Release Capsules CIIPfizer has efforts underway to resolve the issues raised in the REMOXY Complete Response Letter and stated in its earnings call on January 31, 2012 that it expects to conduct two bioavailability studies in the second quarter of 2012 and then meet with the FDA in the third quarter to discuss next steps.  The issues raised in the Complete Response Letter relate primarily to manufacturing.
  • REMOXY, an investigational drug, is a unique long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR technology, which is covered by issued patents and pending patent applications owned by us, REMOXY is designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.

  • POSIDUR (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. Preparation of our briefing package is well underway for our scheduled pre-NDA meeting with the FDA in the summer of 2012, with a potential NDA submission later in the year, depending on FDA feedback. 
  • POSIDUR is our 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 currently hold worldwide commercialization rights to POSIDUR following the notice given in the first quarter of 2012 by Hospira and Nycomed to terminate their collaborations related to the program.

  • 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 del
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  • SOURCE DURECT Corporation
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