FDA agrees to filing of the full response to the Posimir Complete Response Letter as a complete class 2 resubmission. DURECT Corporation
DURECT Corporation announced that the 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.
The Posimir clinical development program was designed to evaluate the safety and efficacy of a single dose of Posimir to treat post-surgical pain for up to three days. In two completed adequate and well-controlled clinical trials, conducted in patients undergoing inguinal hernia repair and subacromial decompression (shoulder) surgeries respectively, Posimir demonstrated a significant decrease in pain and opioids consumed over the 0-72 hour period following surgery as compared to placebo.
DURECT believes that these completed trials support the safety and efficacy of Posimir in post-operative pain and meet the requirements to be considered pivotal clinical trials. In all, the Company has completed 16 clinical trials in the Posimir program, involving over 1,400 patients, over 850 of whom received Posimir, with the remainder in control groups. DURECT believes this is a sufficiently sized safety database. DURECT further believes that, with safety data from the PERSIST trial included, there are now sufficient data to address FDA's issues raised in the CRL.
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