Pacira Pharma Offers Added Data Support Safety of EXPAREL in Peripheral Nerve Block

Pacira Pharmaceuticals, Inc.

today announced data demonstrating that EXPAREL^® (bupivacaine liposome injectable suspension) used in peripheral nerve blocks has comparable safety to placebo and bupivacaine HCl. The analysis, based on a review of six Phase 1-3 clinical trials, will be presented during a podium session at the annual meeting of the American Society of Anesthesiologists in New Orleans this week. “Our review of this peripheral nerve block clinical program found that EXPAREL administered at doses up to 266 mg as a femoral, intercostal or ankle block exhibited a similar safety profile to both placebo and bupivacaine HCl,” said Brian Ilfeld, M.D., the study's lead investigator and chair for clinical research for the Division of Regional Anesthesia at the University of California San Diego. “This safety profile involving peripheral nerve blocks is similar to that found with wound infiltration and suggests that EXPAREL will have the same safety success with peripheral nerve blocks as it has exhibited for wound infiltration and hundreds-of-thousands of applications.” The comparative analysis found that all groups experienced a similar rate of adverse events (AEs) — 76% for EXPAREL vs 76% for placebo vs 61% for bupivacaine HCl — and that these 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. Additionally, the EXPAREL and placebo groups experienced a similar incidence of: * Serious AEs (8% for EXPAREL vs 10% for placebo); none of these were assessed as being related to the study drug * Nervous system AEs (21% in both groups) * Cardiac AEs (9% vs 12%, respectively) Older patients and patients with more co-morbidities were more prone to experience adverse events, as expected, and this trend was true across all groups. “Building on the solid foundation of EXPAREL data that formed the basis of our sNDA for an expanded nerve block indication, we are pleased to announce that the first comprehensive review of our peripheral nerve block program reinforces the safety profile of the product,” added Dave Stack, president, chief executive officer and chairman of Pacira. “If approved for a nerve block indication, we believe that EXPAREL could not only improve patient quality of life by providing multiple days of postsurgical analgesia while eliminating pumps and catheters, but also conserve hospital and provider resources associated with the placement and management of continuous nerve blocks.” EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. Pacira has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a nerve block indication for EXPAREL, with a target Prescription Drug User Fee Act (PDUFA) date of March 5, 2015.