Post-Operative Pain Control with Extended-Release Bupivacaine Formulation. Clinical Trial Results in Inguinal Hernia Repair
- 15 March 2008
SABER™-Bupivacaine (POSIDUR™) is a semi-viscous solution of sucrose acetate isobutyrate formulation containing 12% bupivacaine, an amide-type local anesthetic.
SABER-Bupivacaine, created by DURECT Corporation, is intended to provide prolonged post-surgical pain relief, reduce reliance on opioid analgesic medications, and improve post-operative recovery by slowly releasing bupivacaine over a period of several days.
Current results of the Phase IIb, dose-finding, randomized controlled trial in patients undergoing open inguinal hernia repair demonstrate utility of the product, systemic and local safety, and the analgesic and opioid-sparing effects of SABER-Bupivacaine when deposited at the surgical site in doses up to 5.0 mL (660 mg bupivacaine). Continuous infusions of local anesthetics into the surgical wound utilizing various catheter and pump systems have demonstrated utility and clinical benefits of such treatment approach in a variety of surgical procedures. SABERBupivacaine is designed to provide continuous delivery of bupivacaine to local tissues where it is applied. Clinical trials in different surgical settings are ongoing to investigate the safety and efficacy of SABER™- Bupivacaine as part of the clinical development program.
Current results of the Phase IIb, dose-finding, randomized controlled trial in patients undergoing open inguinal hernia repair demonstrate utility of the product, systemic and local safety, and the analgesic and opioid-sparing effects of SABER-Bupivacaine when deposited at the surgical site in doses up to 5.0 mL (660 mg bupivacaine).
Nicholson D., Brown C., Turner R., Hadj A., Watts R., Shah J., Abrouk N., Lissin D., Langecker P. American Hernia Society, March 15, 2008