CHMP positive for expanded indication of Exparel to include children as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds
Pacira BioSciences, Inc. 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 III 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.
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