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

ree 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.
  • 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. In May 2013, Pfizer stated that they had met with the FDA in March 2013 to discuss their plan to address the Complete Response Letter, and that they had received written guidance from the FDA in May 2013 regarding required next steps, including additional clinical studies, to address the letter. We understand from Pfizer that these additional clinical studies include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified REMOXY formulation. Based on this guidance from the FDA, Pfizer stated that they are considering their options with respect to REMOXY. Further, if Pfizer elects to continue development of REMOXY, which we expect will be determined in the fall of 2013, Pfizer stated that they would not expect to resubmit the NDA, addressing the deficiencies identified in the Complete Response Letter, before mid-2015.
    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.
  • Transdermal Development Candidates. DURECT has two transdermal products that are in mid- to late-stage development with features tha
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  • SOURCE DURECT Corporation
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