DURECT Announces Plans for a New POSIDUR Clinical Trial

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DURECT Corporation
DRRX
announced that, based on feedback from the FDA, it plans to conduct a new POSIDUR™ (SABER®-Bupivacaine) Phase 3 clinical trial consisting of approximately 300 patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. DURECT anticipates beginning the trial in the fall of 2015 and expects that it will take approximately one year to complete enrollment. "With the FDA's guidance in hand, we now have a clear path forward for POSIDUR," stated James E. Brown, President and CEO of DURECT. "We believe that the data from this additional clinical trial will be supportive of the data we have seen in our other pivotal trials in hernia repair and shoulder surgery, and that these three pivotal trials will support a robust NDA resubmission, for which there would be a 6 month review per PDUFA guidelines. We have previous clinical trial experience with laparoscopic cholecystectomy, which is one of the most common general surgeries performed in the U.S. each year. We believe this is an excellent surgical model and that our overall clinical program for POSIDUR will support a broad label." About the new Phase 3 Clinical Trial The study will be a randomized, parallel-group, double-blind, placebo-controlled, multicenter trial of POSIDUR in patients undergoing laparoscopic cholecystectomy. The objective of the study will be to evaluate the safety and efficacy of POSIDUR for the management of postoperative pain. Approximately 300 patients will be randomized on a one-to-one basis to receive either POSIDUR or placebo as a one-time intra-incisional instillation at the close of surgery. The primary efficacy endpoint will be pain intensity on movement over 0-72 hours after surgery. Laparoscopic cholecystectomy Cholecystectomy is a surgical procedure for removal of the gallbladder. Laparoscopic cholecystectomy, which is done using a camera and instruments inserted through a set of small incisions in the abdomen, has largely supplanted the traditional open approach, which requires an abdominal incision several inches in length. Approximately 800,000 such procedures are performed in the U.S. each year, most of them on an outpatient basis. In a previous clinical trial consisting of 50 patients, when using the statistical analysis that will be employed in the upcoming trial, POSIDUR demonstrated an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.0235) when compared with the active control bupivacaine hydrochloride.
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