Durect Corporation Announces Outcome of FDA Advisory Committee Meeting for Posimir
CUPERTINO, Calif., Jan. 17, 2020 /PRNewswire/ -- Durect Corporation (Nasdaq: DRRX) today announced that 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," stated 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."
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.
About the Posimir Clinical Development Program
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 opioid consumption 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. (Article from : www.drugs.com)