With rejection, FDA says Durect's pain treatment Posidur needs further safety studies

Durect ($DRRX) suffered a regulatory setback with the FDA rejection of its Posidur treatment for postoperative pain. The treatment uses the company's SABER technology to deliver bupivacaine for up to three days after surgery, but the FDA said in its complete response letter that it needed further safety data for the proposed label. "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 cited in the Complete Response Letter," Durect CEO James Brown said in a statement. Release

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