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Pacira Receives European Commission Approval for EXPAREL® (bupivacaine liposome injectable suspension) for the Treatment of Postsurgical Pain
--Approval based on four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery-- --EXPAREL is the first long-acting non-opioid
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"--Approval based on four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery--\n --EXPAREL is the first long-acting non-opioid option for field block and brachial plexus or femoral nerve block approved in Europe-- PARSIPPANY, N.J., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NADSAQ: PCRX), the leading global provider of non-opioid pain management options, today announced that the European Commission has granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults. “We are pleased to see news of the European Commission’s approval of EXPAREL and look forward to the opportunity to bring a safe and effective opioid alternative to surgical patients across Europe,” said Dave Stack, Chief Executive Officer and Chairman of Pacira BioSciences. “Europe has long been at the forefront of enhanced recovery after surgery – or ERAS – models of care. With the European Commission’s broad approval for EXPAREL across a wide variety of surgical settings and administration techniques, we see a well-defined position for EXPAREL to play an integral role in further optimizing postsurgical protocols and accelerating postoperative recovery.” The European Commission approval was based on the results of four pivotal Phase 3 studies that demonstrated improvements in pain reduction and opioid use. These studies include: Lower Extremity Nerve Block Study: This study assessed the safety and efficacy of EXPAREL as a femoral nerve block in patients undergoing total knee arthroplasty. Results demonstrated that EXPAREL resulted in a significant reduction in cumulative pain scores over 72 hours compared to placebo. A higher percentage of patients who received EXPAREL were pain-free, consumed fewer opioids and reported higher satisfaction with their pain control compared with placebo.Upper Extremity Nerve Block Study: This study assessed the safety and efficacy of EXPAREL as an interscalene brachial plexus nerve block in patients undergoing total shoulder arthroplasty or rotator cuff repair. Results demonstrated that EXPAREL significantly improved pain control and reduced opioid consumption through 48 hours compared with...