Pacira Says Data Shows Safety Of EXPAREL Similar To Placebo And Bupivacaine HCl

(RTTNews) - Pacira Pharmaceuticals, Inc. (PCRX) on Monday announced data showing that EXPAREL used in peripheral nerve blocks has comparable safety to placebo and bupivacaine HCl.

The comparative analysis found that all groups experienced a similar rate of adverse events — 76% for EXPAREL vs 76% for placebo vs 61% for bupivacaine HCl — and that those appeared to be related to the procedure or opioid rescue rather than the study medication itself. The most common events were in the gastrointestinal disorders class, followed by general disorders/administration site conditions and nervous system disorders.

EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.

Pacira has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for a nerve block indication for EXPAREL, with a target Prescription Drug User Fee Act date of March 5, 2015.