Complete response for Durect's Posidur

Durect Corp. (NASDAQ:DRRX) said FDA issued a complete response letter for an NDA for Posidur bupivacaine to treat postoperative pain. According to Durect, FDA said additional safety studies need to be conducted. Durect said it will work with FDA on next steps for Posidur, an injectable biodegradable gel for sustained-release delivery of bupivacaine. The NDA was submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...