FDA approval of expanded approval for expanded Exparel label to include two additional nerve block indications – Pacira Biosciences

Pacira BioSciences, Inc. announced that the 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.

“We are thrilled that this 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 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 III 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.

“The addition of these new blocks, coupled with the previously approved interscalene brachial plexus nerve block and the ability to utilize Exparel as a fascial plane block provides clinicians with a wide array of applications to treat postsurgical pain with long-lasting, non-opioid analgesia via a single dose administration,” said Jeffrey Gadsden, MD, Chief of Orthopaedic, Plastic, and Regional Anesthesiology and Professor of Anesthesiology at Duke University School of Medicine. “Enhanced recovery protocols built around Exparel regional and fascial plane blocks continue to play a critical—and expanding—role in achieving increased clinician and patient preference to avoid opioids and achieve same-day discharge when appropriate.”