Durect announced the receipt of a complete response letter from the FDA regarding the company's application seeking approval of Posidur (bupivacaine) for post-surgical analgesia. The drugmaker said the agency noted that the filing "does not contain sufficient information to demonstrate that the injectable therapy is safe when used in the manner described," adding that further clinical safety studies are required.
The FDA accepted Durect's submission for Posidur, which uses the company's SABER technology, in June last year. The drugmaker said it is evaluating the issues raised in the agency's complete response letter, with CEO James E. Brown adding that "in the coming months, we intend to work with the FDA to gain more clarity on the next steps that would be required to address the issues."
Shares in the company fell as much as 28 percent on the news.
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