(Reuters) – Independent experts on the FDA advisory panel on Thursday were separated from the approval of Durect Corp's non-opioid panellists to manage post-surgical pain.
The panel members questioned the efficacy of drugs and raised concerns about the unrest, vomiting and bruising at the surgical site that some patients had during the study.
Six members voted in favor, and a further six voted against the drug Posimir, a reformed form of the anesthetic bupivacane which aims to provide pain relief for up to three days after surgery.
“It's a bit better than a placebo, but very slightly better (so) as well as some safety concerns that may be there, the benefit to risk calculating presents challenging,” said Abigail Shoben, a member. panels from Ohio State University to vote against the approval.
Members were also concerned about how the drug was administered directly into surgery, with some requesting further studies on the effects of the drug when administered intravenously.
“The data was inconsistent and there are some shortcomings that do not make sense of the rationale I have heard,” said Joseph O 'Brien, the National Scoliosis Foundation's chief executive in Massachusetts, who voted in favor of obtaining permission.
“Despite all these concerns, at the end of the day, we need an opioid-costing medication,” he said.
The FDA is urging companies to develop alternatives to opioid based painkillers, as the United States tackles the problem of prescription addiction which has claimed the lives of over 700,000 people since 1999.
Posimir Durect is expected to provide pain relief for up to 72 hours, and local anesthetic effects such as bupivacaine, widely administered as a painter, lasts about four to six hours.
The panel's recommendation plays an important role in the FDA's final decision. The agency refused to approve Posimir in 2014, citing many safety details.
Reporting by Trisha Roy and Saumya Sibi Joseph in Bengaluru; Edited by Arun Koyyur and Amy Caren Daniel
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