Posted by Michael Wonder on 07 Apr 2018
Pacira announces FDA approval of supplemental new drug application for Exparel as a nerve block to produce regional analgesia
6 April 2018 - Exparel is now an opioid-free option for use as an interscalene brachial plexus block for upper extremity surgeries.
Pacira Pharmaceuticals today announced that the U.S. FDA has approved its supplemental new drug application to broaden the use of Exparel (bupivacaine liposome injectable suspension) to include administration via interscalene brachial plexus block to produce post-surgical regional analgesia. With this approval, Exparel is the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.
The approval was based on positive data from a Phase 3 study of Exparel in brachial plexus block for shoulder surgeries, in which Exparel demonstrated statistical significance for the primary endpoint of cumulative pain scores over 48 hours as measured by the area under the curve (P<0.0001). EXPAREL also achieved statistical significance versus placebo for the study’s key secondary endpoints as follows: 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).
