BioCentury
ARTICLE | Clinical News

Durect slips after Posidur data

February 10, 2011 2:28 AM UTC

Durect Corp. (NASDAQ:DRRX) was off $0.14 to $3.32 on Wednesday after reporting top-line data from a Phase IIb trial of Posidur to treat post-operative pain. The injectable biodegradable gel for sustained-release delivery of bupivacaine met the co-primary endpoint of non-inferiority to placebo in terms of pain intensity 1-72 hours post-surgery (p<0.05), but missed the co-primary endpoint of superiority to placebo in the total use of opioid rescue analgesia 0-72 hours post-surgery. However, a pre-specified sensitivity analysis of the rescue analgesia endpoint, which Durect said was more appropriate to use given the underlying distribution of opioid use among patients in the trial, did show a significant difference in opioid sparing in favor of Posidur vs. placebo (p<0.05). The double-blind, European trial enrolled in 107 patients undergoing elective arthroscopic shoulder surgery. ...