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FDA Agrees to Review Depot Bupivacaine for Postoperative Pain Relief
Approval decision expected in February (June 20)
The FDA has accepted a new drug application (NDA) for the investigational pain-relief product Posidur (Saber–bupivacaine, Durect Corporation). The product is a postoperative pain relief depot that uses a patented technology (Saber) to deliver bupivacaine and is designed to provide up to 3 days of pain relief after surgery.
The Prescription Drug User Fee Act (PDUFA) goal date — the date on which the FDA expects to complete its review of the NDA — has been confirmed as February 12, 2014.
According to the product’s developer, Posidur (Saber–bupivacaine) is a long-acting local anesthetic for the treatment of postsurgical pain. It is administered during surgery to the surgical site, where it continuously releases therapeutic levels of bupivacaine in a controlled fashion, providing up to 72 hours of local analgesia. Prior to injection, biocompatible excipients are added to the Saber formulation. After injection, the excipients diffuse, leaving a viscous deposit.
Approximately 72 million ambulatory and inpatient procedures are performed in the U.S. each year, according to the Centers for Disease Control and Prevention (CDC). Epidemiological studies indicate that up to 100% of surgical patients experience postoperative pain, with 50% to 75% reporting inadequate pain relief. The current standard of care for postsurgical pain includes oral opiate and non-opiate analgesics, transdermal opiate patches, and muscle relaxants.
Source: Durect Corporation; June 20, 2013.