Durect Reports Positive Results From Posidur Phase IIb Hernia Trial

Durect announced positive results from a 122-patient Phase IIb clinical trial of Posidur for treatment of postoperative pain in patients undergoing inguinal hernia repair.

According to Durect, the trial was designed to be the study upon which Durect and its collaborator Nycomed would base their decision for advancing Posidur into Phase III clinical trials.

The study was conducted in Australia and New Zealand as a multicenter, randomized, double-blind, placebo-controlled study. Study patients were randomized into three treatment groups: 2.5 or 5 mL of Posidur or placebo.

According to the company, the coprimary efficacy endpoints for the study were mean pain intensity on movement area under the curve (AUC), a measure of pain over a period of time, one to 72 hours post-surgery, and the proportion of patients requiring supplemental opioid analgesic medication during the study.

Secondary efficacy endpoints included mean pain intensity on movement AUC over the period one to 48 hours postsurgery, mean total consumption of supplemental opioid analgesic medication, and time to first use of supplemental opioid analgesic medication. The threshold for significance was considered to be at the level.

In relation to the coprimary endpoint of pain reduction as measured by mean pain intensity on movement AUC one to 72 hours post-surgery, the patient group treated with Posidur 5 mL reported 31 percent less pain versus placebo. A 35 percent reduction of pain as measured by mean pain intensity on movement AUC for the period one to 48 hours postsurgery, a secondary endpoint measure, was reported between the Posidur 5 mL treatment group versus placebo, the company said.

Fifty-three percent of the study patients in the Posidur 5-mL group took supplemental opioid analgesic medications versus 72 percent of the placebo patients. Although this positive trend for this coprimary endpoint in favor of the Posidur 5 mL group was not statistically significant, both secondary endpoints measuring opioid analgesic medication consumption were met at a statistically significant level.

Patient groups treated with Posidur 2.5 and 5 mL showed comparable safety profiles as the patient groups treated with placebo, and the drug administration appeared well-tolerated.