Phase 3 Study of Posidur for Post-Op Pain Relief
Durect announced results from its Phase 3, BESST study of Posidur for post-operative pain relief. BESST is an international, multi-center, randomized, double-blind, controlled trial evaluating the safety and efficacy of Posidur vs. placebo in one abdominal surgical procedure and vs. an active comparator (bupivacaine injection) in two other abdominal surgical procedures.
The co-primary endpoints were pain intensity, measured by mean pain intensity on movement (normalized) AUC during the period 0–72 hours post dose, as well as the use of opioid analgesics over the first three days following surgery. Patients treated with Posidur 5mL (660mg) reported a mean pain reduction of approximately 7% compared to the placebo group (P=0.1466).
The Posidur group also reported approximately 16% less opioids consumed vs. the placebo group (P=0.5897). While the results trended positive for both pain reduction and reduction of supplemental opioid use in the first three days after surgery, they did not reach statistical significance.
Posidur is a post-operative pain relief depot that utilizes Durect's patented Saber technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery.
For more information, call (408) 777-1417 or visit www.durect.com.