Durect Corporation announced that it has submitted a New Drug Application (NDA) to the 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.
Durect expects that the FDA will notify if their NDA submission has been accepted for filing within 74 days of submission, which the FDA bases on their initial 60-day review of application completeness. If accepted for filing, the FDA would be expected to assign a PDUFA date of 10 months after the submission.
Posidur will provide a non-opioid alternative treatment option for post-surgical pain if approved by the FDA.
For more information, call (408) 777-1417 or visit www.durect.com.