Pacira BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to expand the EXPAREL (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa. An adductor canal block is used for anesthesia and analgesia for surgery of the knee, medial lower leg, and ankle surgeries. A sciatic nerve block in the popliteal fossa is used for anesthesia and analgesia for foot, ankle, achilles tendon, and other lower leg surgeries.

The approval is supported by two successful randomized, double-blind, active-controlled, multicenter Phase 3 studies designed to evaluate the efficacy, safety, and pharmacokinetics of EXPAREL versus bupivacaine HCl. One study evaluated EXPAREL as a single-dose adductor canal block and the second study evaluated EXPAREL as a single-dose sciatic nerve block in the popliteal fossa. Both studies met their primary endpoints by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (P<0.01).

Additionally, EXPAREL achieved statistical significance for the studies? secondary endpoint of reduced postsurgical opioid consumption (P<0.01). EXPAREL as a sciatic nerve block in the popliteal fossa also achieved statistical significance for the percentage of opioid-free subjects (P<0.01).

In both studies, EXPAREL maintained a safety profile consistent with bupivacaine HCl.