A FDA advisory committee has issued an evenly split decision on Durect’s extended-release formulation of bupivacaine. Durect’s share price fell 12% after half of the panel of painkiller experts recommended against approving Posimir on the basis of the available evidence.
The FDA rejected Posimir in 2014 amid concerns about its safety and tolerability profile, prompting Durect to go away and run another phase 3 to allay the agency’s worries. Durect refiled for approval in the belief the study and re-analysis of existing data adequately addressed the concerns raised by the FDA back in 2014.
However, the data failed to wow the panel of experts convened by the FDA to inform its decision on whether to approve Posimir. Some of the panel were underwhelmed by both the safety and the efficacy data.
“It is slightly better than placebo, but very slightly better. [That], coupled with some potentially minor safety concerns, make the benefit-to-risk calculation challenging,” Abigail Shoben, a panel member from Ohio State University, said, according to Reuters. Shoben voted against approval.
Even some of the panelists who voted in favor of approval did so while pointing to problems with the filing. Joseph O’Brien, CEO of the National Scoliosis Foundation, called the data “inconsistent,” adding that “there are some unknowns that don’t make sense with the rationale I heard.” Despite that, O’Brien recommended approval of Posimir.
O’Brien’s reason for voting in favor of approval may represent Durect’s best hope of getting Posimir to market using the available data. While O’Brien had concerns with the data, he backed the drug as there is “a need for opioid-sparing medication.”
That need has been brought into sharp focus in the years since Durect previously filed for approval of Posimir. The FDA recognized the need over those years, leading it to launch initiatives designed to cut public exposure to opioids. If FDA wants to get a new non-opioid painkiller to patients to help that effort, it may still approve Posimir despite the equivocal response of the advisory committee.