FDA Advisory Committee issues Complete Response Letter for Posidur and requires further studies - Durect Corp

DURECT Corporation announced that the FDA has issued a Complete Response Letter for Posidur (SABER�-Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia. Based on its review, the FDA has determined that they cannot approve the NDA in its present form, stating the NDA does not contain sufficient information to demonstrate that Posidur is safe when used in the manner described in the proposed label, and the FDA has indicated that additional clinical safety studies need to be conducted. DURECT is evaluating the issues described in the Complete Response Letter and plans to have further discussions with the FDA around them.