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Pacira BioSciences Completes Enrollment in Multicenter Registration Study of EXPAREL® in Pediatric Patients
Top-line data expected in fourth quarter of 2019 PARSIPPANY, N.J., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), a leading
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"Top-line data expected in fourth quarter of 2019\nPARSIPPANY, N.J., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), a leading provider of innovative non-opioid pain management options, today announced that it has reached full enrollment of its Phase 3 study of EXPAREL® (bupivacaine liposome injectable suspension) administered as a single-dose infiltration in pediatric patients aged six to less than 17 years undergoing spinal or cardiac surgeries. The company intends that these study results will provide the foundation for a supplemental New Drug Application submission to the U.S. Food and Drug Administration (FDA) seeking expansion of the EXPAREL label to include children aged six and over.\n “Pediatric patients—arguably our most vulnerable surgical population—urgently need opioid-free options to manage postsurgical pain. This is particularly true for children six to 12 years of age who do not have any FDA-approved local anesthetic options today,” said Dave Stack, chairman and chief executive officer of Pacira. “Currently, the standard way to manage moderate to severe pain in these patients is through the use of opioids, which we know are fraught with unwanted and potentially life-threatening side effects.” The study, which is known as PLAY, enrolled 98 patients to evaluate the pharmacokinetics and safety of EXPAREL for two patient groups: patients aged 12 to less than 17 years and patients aged 6 to less than 12 years. The study includes bupivacaine HCl as an active comparator arm for the older patient population. In addition to the PLAY study, the company’s pediatric program includes collaboration with FDA to define a Phase 3 registration study of EXPAREL as a nerve block in the pediatric setting. The company’s label expansion strategy also includes launching a Phase 3 registration study evaluating EXPAREL versus bupivacaine HCl as a lower extremity nerve block in adult patients undergoing foot and ankle surgeries. “Looking ahead, we believe EXPAREL is well-positioned for long-term market leadership with a broad label that will include pediatrics and flexible regional approaches that utilize ultrasound-guided field and nerve blocks. In addition, we have a growing partnership network of EXPAREL-based enhanced recovery after surgery collaboratives and a highly successful partnership with Johnson & Joh...