The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Exparel (bupivacaine liposome injectable suspension) to include both single-dose sciatic nerve block in the popliteal fossa as well as femoral nerve block in the adductor canal.
The sNDA is supported by data from 2 randomized, double-blind, active-controlled phase 3 studies (ClinicalTrials.gov Identifier: NCT05157841 [Study 1], NCT02713178 [Study 2]) that compared the efficacy and safety of Exparel to bupivacaine hydrochloride as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy, and as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty.
Results from both studies showed that treatment with Exparel met the primary endpoint demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine hydrochloride. Moreover, Exparel was associated with a statistically significant reduction in postsurgical opioid consumption (key secondary endpoint) through 96 hours compared with bupivacaine hydrochloride.
“We believe these positive datasets provide the basis for broadening the Exparel label to include both sciatic and femoral nerve blocks, which represents the opportunity to manage pain with a single 10mL dose of Exparel for more than 3 million lower extremity procedures annually,” said Dave Stack, chief executive officer and chairman of Pacira BioSciences. “Importantly, this potential approval would give clinicians a safe and effective tool to provide 4 days of postsurgical pain control, reduce opioid requirements, and continue to migrate relevant orthopedic procedures to the outpatient setting.”
A Prescription Drug User Fee Act (PDUFA) action date of November 13, 2023 has been set for the application.
Exparel is currently approved in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
1. Pacira announces FDA acceptance of sNDA for Exparel nerve blocks to produce regional analgesia in lower extremity procedures. News release. Pacira BioSciences, Inc. March 29, 2023. Accessed March 31, 2023. https://www.globenewswire.com/news-release/2023/03/29/2636622/0/en/Pacira-Announces-FDA-Acceptance-of-sNDA-for-Exparel-Nerve-Blocks-to-Produce-Regional-Analgesia-in-Lower-Extremity-Procedures.html
2. Pacira BioSciences announces positive topline data from phase 3 study of Exparel as a single-dose sciatic nerve block in the popliteal fossa for bunionectomy. News release. Pacira BioSciences, Inc. September 21, 2022. Accessed March 31, 2023. https://investor.pacira.com/news-releases/news-release-details/pacira-biosciences-announces-positive-topline-data-phase-3-0
3. Pacira BioSciences announces positive topline data from phase 3 study of Exparel as a single-dose femoral nerve block in the adductor canal for total knee arthroplasty. News release. Pacira BioSciences, Inc. September 7, 2022. Accessed March 31, 2023. https://investor.pacira.com/news-releases/news-release-details/pacira-biosciences-announces-positive-topline-data-phase-3-study