Durect falls on pain data

Durect Corp. (NASDAQ:DRRX) fell $0.44 (38%) to $0.74 on Friday after reporting top-line data from the Phase III BESST trial of Posidur to treat post-operative pain. In patients undergoing laparoscopically assisted colectomy, the injectable biodegradable gel for sustained-release delivery of bupivacaine missed the co-primary endpoints of reducing mean pain intensity on movement scores and median total supplemental opioid use from 0-72 hours post-treatment vs. placebo (p=0.1466 and p=0.5897, respectively). The double-blind, international trial enrolled 305 patients undergoing various abdominal surgical procedures.

Last year, Durect reported data from a Phase III trial in 107 patients undergoing elective arthroscopic shoulder surgery showing that Posidur met the co-primary endpoint for pain intensity, but missed the co-primary endpoint for total use of opioid rescue analgesia vs. placebo. In 2008, the company reported data from a Phase IIb trial in 120 patients undergoing open inguinal hernia repair showing that Posidur met both co-primary endpoints vs. placebo. Durect plans to hold a pre-NDA meeting with FDA by mid-year (see BioCentury Extra, Feb. 9, 2011). ...