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Pacira Receives Positive CHMP Opinion for EXPAREL® (bupivacaine liposome injectable suspension) for the Treatment of Postsurgical Pain
-- CHMP opinion supported by four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery -- -- European Commission decision on
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"-- CHMP opinion supported by four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery --\n -- European Commission decision on the Marketing Authorization Application (MAA) expected in November 2020 -- PARSIPPANY, N.J., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), a leading provider of innovative non-opioid pain management options, today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for EXPAREL for postsurgical analgesia. “This positive CHMP opinion brings Pacira one step closer to realizing our vision of establishing Pacira as the global leader in innovative non-opioid pain management,” said Dave Stack, Chief Executive Officer and Chairman of Pacira BioSciences. “We are particularly pleased with the CHMP’s broad recommendation for EXPAREL across a variety of surgical settings and administration techniques. We look forward to the EMA’s final decision and the opportunity to bring a safe and effective opioid alternative to surgical patients across Europe.” The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The CHMP recommended granting EXPAREL marketing authorization with the following indication: EXPAREL is indicated 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. EXPAREL should be administered in a setting where trained personnel and appropriate equipment are available. The European Commission will review the CHMP opinion and is expected to adopt a final decision in November 2020. The decision will be applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein. The CHMP positive opinion 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 ...