Hung jury vote leaves FDA with a difficult decision on Durect's non-opioid painkiller
A split advisory panel vote on Durect’s non-opioid drug to manage post-surgical pain is only going to make the FDA’s task harder.
After FDA staff reviewers issued an internal review that underscored their unease with the side-effect profile of the long-acting anesthetic posimir — on Thursday a panel of independent experts could not reach a consensus on whether to back the therapy.
Six panelists endorsed approval, while the remaining six dissented. The therapy is a formulation of the anesthetic bupivacaine and is designed to manage pain up to three days following surgery after being administered directly into the surgical incision.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.