DURECT Receives POSIMIR® CRL

DURECT announced the U.S. Food and Drug Administration (FDA) has acknowledged that the submission of DURECT's full response to the Complete Response Letter (CRL) it previously received from FDA related to POSIMIR® (bupivacaine extended-release solution) is considered by the FDA to be a complete class 2 response to the CRL. The user fee goal date is December 27, 2019. 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.

"We are pleased that the FDA considers our POSIMIR submission to be complete and has set a user fee goal date of six months after submission," said James E. Brown, President and CEO of DURECT. "New non-opioid pain products are much needed in the post-operative pain setting and we believe that POSIMIR could be an important contributor."

POSIMIR is the Company's investigational post-operative pain relief depot product that utilizes DURECT's patented SABER® technology. POSIMIR is designed to be administered directly into the surgical site to deliver bupivacaine for up to three days after surgery. POSIMIR has not been approved by the FDA for marketing in the U.S. for any indication.

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