DURECT announced the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met yesterday to discuss the Class 2 New Drug Application (NDA) resubmission for POSIMIR® (bupivacaine extended-release solution). In a split vote on the key question, six advisory committee members voted to recommend that the efficacy, safety, and overall risk-benefit profile of POSIMIR support approval, while six did not support approval based on the information presented.
Although the FDA considers the recommendations of the AADPAC, the recommendations by the panel are non-binding. The final decision regarding pending regulatory actions for a product is made by the FDA.
"We appreciated this opportunity to present an in depth overview of our POSIMIR data and discuss it with the committee," said James E. Brown, President and CEO of DURECT. "We are encouraged by the support from a number of the Committee members. We continue to believe the data meets all of the regulatory requirements and that the weight of the evidence supports approval. We look forward to working with the agency as it completes its review of the POSIMIR application."
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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. The FDA had previously assigned a user fee goal date of December 27, 2019; a new user fee goal date has not been assigned. POSIMIR has not been approved by the FDA for marketing in the U.S. for any indication.