- Pacira BioSciences ( NASDAQ: PCRX ) on Tuesday said the European drug regulator's human medicines committee had recommended expanding the indication for its non-opioid treatment Exparel to include its use in children aged 6 years or older to treat postsurgical pain.
- The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of the expanded indication, PCRX said in a statement .
- The approval recommendation was based on the results of a phase 3 study of Exparel in pediatric patients undergoing spinal or cardiac surgeries, PCRX said.
- Exparel was initially approved by the European Commission in Nov. 2020 as a treatment for post-operative pain and postsurgical pain in adults.
- PCRX stock -0.5% to $54.47 in early trading.
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EMA panel backs expanding indication for Pacira's postsurgical pain treatment in kids