BUSINESS NEWS

Pacira Announces FDA Approval of Expanded Exparel Label

NOVEMBER 2023

Pacira BioSciences Inc. announced that the US Food & 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, according to a release. 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.

“We are thrilled that today’s approval offers clinicians and patients another option for achieving long-lasting non-opioid pain control with Exparel and an increased ability to transition procedures to the ambulatory environment,” said Dave Stack, chief executive officer and chairman of Pacira BioSciences, in the release. “In line with our corporate mission to provide a non-opioid to as many patients as possible, this new indication provides additional flexibility in the use of Exparel as a regional analgesic for more than 3 million lower extremity procedures annually, further increasing the utility of Exparel for major orthopedic procedures.”

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), according to the release.

Read the full release.