DURECT Corporation announces the outcome of the FDA Advisory Committee meeting for Posimir which resulted in a split vote on the treatment of post-surgical pain .
DURECT Corporation has announced that the (FDA Anesthetic and Analesic Drug Products Advisory Committee (AADPAC) met to discuss the Class 2 New Drug Application (NDA) resubmission for Posimir (bupivacaine extended-release solution).
In a split vote on the key question, six advisory committee members voted to recommend that the efficacy, safety, and overall risk-benefit profile of PosimirR support approval, while six did not support approval based on the information presented. Although the FDA considers the recommendations of the AADPAC, the recommendations by the panel are non-binding. The final decision regarding pending regulatory actions for a product is made by the FDA.
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