DURECT Announces FDA Acceptance of New Drug Application (NDA) Submission for POSIDUR® (SABER®-Bupivacaine)

DURECT Corporation

today announced that the New Drug Application (NDA) for the investigational product POSIDUR (SABER-Bupivacaine) has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. DURECT submitted the NDA as a 505(b)(2) application. The Prescription Drug User Fee Act (PDUFA) goal date (the date the FDA expects to complete its review of the NDA) has been confirmed as February 12, 2014. (Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO) "We're extremely pleased that this NDA submission has been accepted for review and that our PDUFA date is now less than eight months away. If approved by the FDA, POSIDUR will provide a non-opioid alternative treatment option for post-surgical pain," James E. Brown, D.V.M., President and CEO of DURECT, stated. "Treating post-surgical pain with a true long-acting local anesthetic has the potential benefit of reducing the need for opioids and their associated systemic side effects that can prolong the time to recovery and result in extended hospital stays." About POSIDUR POSIDUR is a post-operative pain relief depot that utilizes DURECT's 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.