Pacira BioSciences (PCRX) announces positive results from its Phase 3 PLAY study of EXPAREL (bupivacaine liposome injectable suspension) administered as a single-dose infiltration in pediatric patients undergoing spinal or cardiac surgeries. The study enrolled 98 patients.
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.
These results will provide the foundation for the company’s sNDA in H1 2020 seeking expansion of the EXPAREL label to include children aged six and over.
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