FDA says Durect's pain relief drug Posidur needs additional safety studies

13 February 2014

US drugmaker Durect Corp (Nasdaq: DRRX) says that the US Food and Drug Administration has issued a Complete Response Letter for Posidur (SABER-bupivacaine), the firm’s investigational drug for post-surgical analgesia. Durect's shares fell about 30%, closing at $1.95 on Wednesday on the news.

Based on its review, the FDA said it cannot approve the new drug application in its present form, stating the New Drug Application does not contain sufficient information to demonstrate that Posidur is safe when used in the manner described in the proposed label. The FDA has indicated that additional clinical safety studies need to be conducted.

Addressing the issues

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