Durect's Posimir: NDA Resubmission Raises Similar Safety Issues

How to score adverse events for Durect's surgical pain treatment could determine whether US FDA advisory committee recommends bupivacaine extended-release solution; agency questions whether Posimir's formulation may cause neurological adverse events.

Dissection forceps or hemostatic forceps passing in surgeon hand by team surgeons in surgery center for interventions with instruments in surgeon operation electrosurgery with thoracotomy microsurgery
Posimir is proposed for post-surgical local pain relief. • Source: Shutterstock

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