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

ator Zogenix reporting positive results from the Relday Phase 1 study and rapid expansion of that study to include a higher dose, which today also reported positive results."

Update of Programs:

  • REMOXY (oxycodone) Extended-Release Capsules CII.  Pfizer has efforts underway to resolve the issues raised in the REMOXY Complete Response Letter, which are primarily related to manufacturing. Pfizer held a meeting with the FDA in late March 2013 to discuss their proposed resubmission plan for REMOXY.  On April 30, Pfizer stated that they had a productive meeting with the FDA and received guidance that is helping to inform the next steps in addressing the issues raised by the FDA in the Complete Response Letter.  In 2013, we received issuance of an additional ORADUR® patent that would protect REMOXY in the U.S. until at least 2031. 
    On April 16, 2013, the FDA announced two actions relevant to abuse-deterrent opioids.  First, after reviewing the available science, the FDA will allow the label for opioids to describe abuse-deterrent properties.  Second, the FDA will not accept or approve any generic forms of the original OxyContin ER.
    REMOXY, an investigational drug, is a unique long acting oral formulation of oxycodone intended to treat moderate-to-severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. 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. 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.  We expect that the FDA will n
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