FDA Panel Split On Approval Of Reformulated Bupivacaine For Pain

A panel of FDA advisors were split on whether FDA should approve Durect Corporation’s Posimir (SABER-bupivacaine extended-release solution) for post-surgical pain relief, touted by the company as a drug that would reduce use of opioids for at least 24 hours after surgery. During a Thursday (Jan. 16) advisory committee meeting, experts pointed to potential problems that could stem from the route of administration for Posimir, and they questioned whether the efficacy data showed a significant enough improvement in pain relief...