Independent experts on an FDA advisory board Thursday were split over the clearance of Durect Corp’s non-opioid painkiller to manage post-surgical pain.
The board members questioned the drug’s effectiveness and raised concerns over nausea, vomiting, and bruising at the surgical site experienced by some sufferers during the research.
Six members voted in favor, while the remaining voted against the approval of Posimir, a reformulated model of the anesthetic bupivacaine that intends to provide ache relief for up to three days after surgical procedure.
The members were additionally concerned about the way the drug was delivered directly into the surgical incision, with some asking for additional research on the consequences of the drug when administered intravenously.
The FDA has been pushing corporations to develop alternatives to opioid-based painkillers, as the U.S. grapples with the problem of opioid habit that has killed over 700,000 Americans since 1999.
Durect’s Posimir is expected to alleviate pain for as much as 72 hours, while the effects of native anesthetics such as bupivacaine, widely administered as painkillers, last for about four to six hours.
The board’s suggestion plays an influential role in the FDA’s ultimate decision. The firm had refused to approve Posimir in 2014, citing insufficient safety information.