Business
Pacira Announces FDA Acceptance of sNDA for Exparel Nerve Blocks to Produce Regional Analgesia in Lower Extremity Procedures
TAMPA, Fla., March 29, 2023 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"TAMPA, Fla., March 29, 2023 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has accepted the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL label to include both single-dose sciatic nerve block in the popliteal fossa as well as femoral nerve block in the adductor canal. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is November 13, 2023. The sNDA is supported by two successful Phase 3 studies in which EXPAREL achieved statistically significant and clinically meaningful reductions in postsurgical pain and opioid consumption through 96 hours compared with bupivacaine HCl following lower extremity surgical procedures including bunionectomy and total knee arthroplasty. In both studies EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl. “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 10 mL 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 four days of postsurgical pain control, reduce opioid requirements, and continue to migrate relevant orthopedic procedures to the outpatient setting.” EXPAREL is currently indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Since initial approval in 2011, more than 12 million U.S. patients have been treated with EXPAREL. About Pacira Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to providing a non-opioid option to as many patients as possible to redefine the role of opioids as rescue therapy only. The company is also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain, and spasticity. Pacira h...