FDA advisory panel divided over whether to approve Durect's Posimir for post-operative analgesia

The FDA'sadvisory board was divided over whether to approve Durect's Posimir for post-surgery analgesia, with a vote of 6 to 6Panel members questioned the effectiveness of the drug and expressed concern about side effects, including nausea, vomiting and surgical bruisingThe company's shares fell 16 percent after the news brokePosimir can provide pain relief for up to 72 hours, while local anesthetics such as bubcarin usually last about 4 to 6 hoursDurect cites data from two studies of patients with groin repair and shoulder-to-shoulder decompression surgery, showing that single-dose Posimir significantly reduces pain and opioid use within three days of surgery compared to placebos2014, the FDA rejected the drug's approval, then known as Posidur, and in a complete response letter stated that furtherclinicalsafety studies were neededLast June, Durect submitted a full response to the FDA's question, and the agency set a target review date of December 27However, the FDA said in October that it would discuss the document at a meeting of the advisory committee at the startIn 2020, no new target review date has been setat the meeting, Abigail Shoben, a member of the committee that opposed the approval, said Posimir: "It's a little better than a placebo, but it's just a little bit better, plus there are some potential safety concerns." "The Advisory Group is also concerned about Posimir's method of administration, which is delivered directly to the surgical incision, and some members have called for further study of the drug's effects during intravenous administrationJoseph O'Brien, a member of thepanel, commented, "The data is inconsistent, and some unknowns don't match the fundamentals I know," but he supported it"Because we really need to save on opioiddrugs"