Durect Corporation files response to Complete Response Letter for treatment of post surgical pain

DURECT Corporation announced it has submitted a full response to the Complete Response Letter (CRL) it previously received from FDA related to Posimir (bupivacaine extended-release solution). The submission is intended to address the issues raised in the CRL and seeks FDA approval of Posimir based on what the Company and its advisors believe is adequate evidence of both safety and efficacy.

DURECT commissioned the advisory services of Dr. Lee S. Simon to first evaluate the adequacy of the existing Posimir package to address the issues raised in FDA correspondence, including the CRL, and then to lead the Company's efforts to submit its response to the CRL. Dr. Simon is a physician and research scientist who served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products from 2001 to 2003, and is now a Principal at SDG, LLC, an FDA advisory firm. As the submission is intended to be a full response to the CRL, as opposed to a new NDA submission, the Company expects a six-month FDA review period.