Pacira BioSciences (NASDAQ:PCRX) reported positive results from its Phase 3 study of EXPAREL in pediatric patients undergoing spinal or cardiac surgeries.
EXPAREL is a non-opioid, single-dose, long-acting local analgesic that is FDA-approved for infiltration, field block and brachial plexus nerve block.
The study enrolled 98 patients to evaluate the pharmacokinetics and safety of EXPAREL in patients 12-to-16 and six-to-11 years of age. Study 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 results will be part of the company’s planned supplemental NDA submission to the FDA in the first half of 2020, which will seek label expansion to include children aged six and over. Pacira plans to initiate a second Phase 3 study of EXPAREL, administered as a nerve block in the pediatric setting, in 2020.
“Pediatrics will be a very important addition to the EXPAREL label as there is an urgent need for non-opioid options for managing moderate-to-severe postsurgical pain in this vulnerable population,” Dave Stack, Pacira’s chairman and CEO, said in a statement.
