Durect Corp plans response to FDA Complete Response Letter for Posimir for treatment of post surgical pain.

DURECT Corporation announced it has completed a comprehensive review of its Posimir (bupivacaine extended-release solution) program and plans to submit a full response to the Complete Response Letter (CRL) it previously received from FDA . The submission will request 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 evaluate the adequacy of the existing Posimir package to address the issues raised in FDA correspondence, including 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. Dr. Simon is a Principal at SDG, LLC, an FDA advisory firm. Under Dr. Simon's leadership, the Company conducted a thorough review of the data and regulatory package for Posimir, including extensive analyses of the data from the PERSIST clinical study which the Company conducted at the FDA's request. The review of the data package was in the context of the feedback received from FDA, including the CRL and other FDA communications, in order to make a determination as to next steps for Posimir.

Based on these analyses, the Company has decided to move forward and Dr. Simon is leading the process of preparing a submission to formally respond to the CRL. As the submission is intended to be a full response to a CRL, as opposed to a new NDA submission, the Company expects a 6-month FDA review period. The Company expects to make the submission in the first half of 2019.