EXPAREL is indicated for single-dose administration to the surgical site to produce postsurgical analgesia.
An analysis of six Phase 1-3 clinical trials will be presented at the annual meeting of the American Society of Anesthesiologists in New Orleans this week. The comparative analysis showed that all groups in the trial experienced a similar rate of adverse events (76 percent for EXPAREL, 76 percent for placebo and 61 percent for bupivacaine HCI). These adverse events appeared to be related to the procedure or opioid rescue and not the EXPAREL itself.
The EXPAREL and placebo groups also experienced similar rates of serious adverse events, nervous system adverse events and cardiac adverse events.
“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,” Dave Stack, president, chief executive officer and chairman of Pacira, said. “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.”
