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US FDA panel divided on approval of Durect's non-opioid drug Posimir

A panel of outside advisers to the U.S. Food and Drug Administration was divided over whether the agency should grant approval to Durect Corp.'s Posimir, a non-opioid painkiller for post-surgical pain, Reuters reported Jan. 16.

The Anesthetic and Analgesic Drug Products Advisory Committee voted 6-6 for the approval of the bupivacaine extended-release solution, which is intended to be administered directly to a patient's surgical site for up to three days after surgery.

Cupertino, Calif.-based Durect had resubmitted an application for the drug after an initial rejection by the regulator in February 2019.

The panel raised questions about the side effects experienced by some patients during Posimir's clinical studies and noted concerns over its method of administration directly into the surgical incision.

Some panel members asked for additional studies investigating the effects of the drug when given intravenously, Reuters reported.

Durect halted trading in its shares on the Nasdaq Capital Market exchange before the panel's meeting Jan. 16.