The Food and Drug Administration (FDA) has approved the use of Exparel (bupivacaine liposome injectable suspension; Pacira Pharmaceuticals) as an interscalene brachial plexus block to produce postsurgical regional analgesia.
Exparel was first approved in 2011 as a single-dose infiltration at the surgical site to produce postsurgical analgesia. The expanded approval means Exparel can be administered to patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.
The sNDA approval was based on results from a Phase 3 study, in which 156 patients undergoing shoulder surgeries were randomized to either receive a single dose of Exparel (133mg in 10mL expanded in volume with 10mL of normal saline for a total volume of 20mL) or placebo 20mL. In this study, there was a statistically significant treatment effect for Exparel compared to placebo in cumulative pain scores through 48 hours (primary endpoint; P<0.0001).
Additionally, statistical significance vs placebo was also achieved in total postsurgical opioid consumption through 48 hours (P<0.0001); opioid-free subjects through 48 hours (P<0.01); and time to first opioid rescue through 48 hours (P<0.0001).
“The ability to provide effective regional analgesia with a single dose of Exparel is a tremendous victory for patients and advances the imperative need for low- or no-opioid pain management strategies,” said Jeffrey Gadsden, MD, Associate Professor of Anesthesiology at Duke University School of Medicine.
For more information visit Exparel.com.