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Pacira Receives Positive CHMP Opinion for EXPAREL® for the Treatment of Postsurgical Pain in Children Aged 6 or Older
-- European Commission decision on the Marketing Authorization Application (MAA) expected in November 2022 -- TAMPA, Fla., Sept. 20, 2022 (GLOBE NEWSWIRE) --
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"-- European Commission decision on the Marketing Authorization Application (MAA) expected in November 2022 --\nTAMPA, Fla., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the leading global provider of non-opioid pain management options, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for an expanded indication of EXPAREL to include use in children aged 6 years and older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds. “This positive CHMP opinion brings Pacira one step closer to realizing another milestone on our corporate mission to provide an opioid alternative to as many patients as possible,” said Dave Stack, Chief Executive Officer and Chairman of Pacira BioSciences. “We look forward to the potential to offer a non-opioid option to children across Europe, while giving clinicians another tool to help optimize clinical outcomes.” The European Commission approval was based on the results of the Phase 3 PLAY study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg. The PLAY study enrolled 98 patients to evaluate safety and the pharmacokinetics of EXPAREL for two patient groups: patients aged 12 to less than 17 years and patients aged 6 to less than 12 years. The European Commission decision is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. The data is still under review in the United Kingdom. EXPAREL was initially approved by the European Commission in November 2020 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. About Pacira BioSciences Pac 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 ...