Durect reveals early results from post-op pain study

Saber-Bupivacaine is based on Durect’s patented Saber delivery technology and is intended to be administered around the surgical site after surgery to provide three days or more of regional pain relief.

The phase II trial is a dose escalation study underway in Australia. The trial is designed to include three cohorts for the treatment of pain in patients following repair of inguinal hernia. Six patients were enrolled in cohort 1 and fifteen patients were enrolled in cohort 2.

Patients in cohort 2 received injections of either Saber-Bupivacaine or commercial bupivacaine – the current standard of care – at the completion of surgery. Patients were allowed to take supplemental analgesic medication to address their breakthrough pain.

Using standardized pain evaluation methodology recognized by regulatory authorities to measure pain relief, patients treated with Saber-Bupivacaine reported better overall mean pain relief over the four days following treatment compared with patients treated with commercial bupivacaine. Patients treated with Saber -Bupivacaine also reported lower pain intensity scores than the control group using a visual analog scale over the four days following treatment.

“The preliminary findings from our phase II study are very significant for the Saber-Bupivacaine development program and Durect in that they are supportive thus far of all our established clinical objectives for this product candidate of safety, a drug delivery duration of three days or more, and in comparison to the current standard of care, improved pain relief and reduction in the use of supplemental analgesic medication,” stated James Brown, CEO of Durect.