The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee split in a 6-6 vote over Durect’s Posimir (bupivacaine extended-release solution) for post-surgical analgesia.
If approved by the FDA, the opioid-sparing drug would be indicated for insertion at the surgical site for post-surgical analgesia. However, the 12-member panel struggled to interpret the drug’s safety and efficacy data.
Ronald Litman, a professor of anesthesiology and pediatrics at the University of Pennsylvania, voted against the product because he believed the risks outweighed the benefits based on the data, but noted that “that might not be the case.”
The panel agreed that post-marketing studies would be needed to study intravenous use of the drug, especially the risk of accidental injection.