Durect's Posimir misses in Phase III for postsurgical pain
Durect Corp. (NASDAQ:DRRX) said Posimir bupivacaine (SABER-Bupivacaine) missed the primary endpoint in the Phase III PERSIST trial to treat postsurgical pain. The company had expected the trial to support an NDA resubmission following its receipt of a complete response letter in 2014.
Top-line data from the double-blind, U.S. trial showed that a single intra-incisional instillation of Posimir at the close of surgery did not significantly reduce pain intensity with movement using an 11-item numeric rating scale (NRS) over the first 48 hours following laparoscopic cholecystectomy compared to standard bupivacaine. The injectable, biodegradable gel is designed for sustained-release delivery of bupivacaine using sucrose acetate isobutyrate. Durect originally submitted the candidate to FDA in 2013 under the product name Posidur to treat postoperative pain. The agency's 2014 complete response letter required additional safety studies (see BioCentury, Feb. 17, 2014)...