DURECT Corporation, a a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, has submitted New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the investigational product Posidur (SABER-Bupivacaine). 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.

"We're extremely pleased to submit this NDA for Posidur to the FDA. If approved by the FDA, Posidur will provide a non-opioid alternative treatment option for post-surgical pain," James E Brown, DVM, 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."

Brown further informed, “We expect that the FDA will notify us whether our NDA submission has been accepted for filing within 74 days of submission, which the FDA bases on their initial 60-day review of the completeness of our application.  If accepted for filing, the FDA would be expected to assign a PDUFA date of 10 months after the submission.”

Brown stressed that the company is in discussions with potential partners regarding licensing development and commercialization rights to Posidur, for which we hold worldwide rights.