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DURECT ANNOUNCES RESULTS OF SABER-BUPIVACAINE STUDY

October 18, 2005

DURECT has announced positive preliminary results from a Phase II dose-escalation study (Cohorts 1-3) in hernia patients in Australia for a postoperative pain relief depot, SABER-Bupivacaine. SABER-Bupivacaine is intended to be administered around the surgical site after surgery to provide three days or more of regional pain relief.

The Phase II study is a dose escalation trial designed for dose-optimization of the product candidate. It includes three cohorts for the treatment of pain in patients following repair of inguinal hernia. Six patients were enrolled in Cohort 1, and 15 patients were enrolled in Cohort 2 and 60 patients in Cohort 3.

Preliminary data indicate that all primary endpoints for the study were achieved. Evaluation of plasma bupivacaine concentrations showed that SABER-Bupivacaine achieved its target delivery profile of providing a delivery duration of over 72 hours with no burst upon injection. No significant clinical adverse events or local or systemic toxicity were observed, and the injections were well-tolerated by the patients.