An FDA advisory committee voted 6-6 in a split decision on whether to approve Durect's Posimir (bupivacaine) for post-surgical analgesia, with panel members questioning the drug's effectiveness and raising concerns over side effects, including nausea, vomiting and bruising at the surgical site. Company shares declined as much as 16% on the news.
Posimir is designed to provide pain relief for up to 72 hours, while the effects of local anaesthetics such as bupivacaine, typically last for about four to six hours. Durect cited data from two studies in patients undergoing inguinal hernia repair and subacromial decompression surgeries demonstrating that compared with placebo, a single dose of Posimir significantly decreased pain and opioid consumption in the three days after surgery.
In 2014, the FDA rejected approval of the drug, then known as Posidur, stating in a complete response letter that further clinical safety studies were required. In June last year, Durect submitted a full response to address the FDA's issues, with the agency assigning a target review date of December 27. However, in October, the FDA said that the filing would be discussed at an advisory committee meeting at the start of 2020 and a new target review date has yet to be assigned.
At the meeting, committee member Abigail Shoben, who voted against approval, said Posimir "is slightly better than placebo, but very slightly better, (that) coupled with some potentially minor safety concerns make the benefit to risk calculation challenging." The advisory panel also expressed concern about administration of Posimir, which is delivered directly into the surgical incision, with some members asking for additional studies on the effects of the drug when administered intravenously.
"The data [were] inconsistent and there are some unknowns that don't make sense with the rationale I heard," commented panel member Joseph O'Brien, who nevertheless backed approval, saying that "despite all these concerns, at the end of the day, we do have a need for opioid-sparing medication."
In the past several days, an FDA advisory committee voted 24-2 against approval of Intellipharmaceutics' abuse-deterrent opioid analgesic Aximris XR (oxycodone extended-release), whilst also voting unanimously against clearance of Nektar Therapeutics' opioid pain drug NKTR-181, also known as oxycodegol. In addition, the advisory panel voted 13-13 over whether to approve Esteve's E-58425, a combination of the opioid tramadol and the anti-inflammatory drug celecoxib, for moderate-to-severe acute pain.
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