FDA Panel Split on Durect Pain Drug

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has delivered a split vote (6 to 6) on the approval of Durect Corp.’s Posimir (bupivacaine extended-release solution) with a proposed indication for administration into a surgical incision to produce post-surgical analgesia. Panel members recognized effectiveness and safety issues in the company’s 10/2019 response to a 2014 FDA complete response letter.

During the panel deliberation, some found the data too confusing to interpret, saying that it barely showed any effect over the placebo. Safety concerns, like increased surgical site bleeding and surgical site infections, were also raised by members and FDA.

Some panel members who supported the drug’s approval were encouraged by its opioid sparing properties, agreeing that reducing opioid use in the post-operative period is an important public health goal.