Pacira Pharmaceuticals said a phase 4 study of its EXPAREL plus bupivacaine demonstrated a decrease in opioid consumption and significantly better pain control versus bupivacaine alone in patients with total knee arthroplasty. The company said 10% of patients in the EXPAREL arm required no opioids for pain control. The study met its co-primary efficacy endpoints, the company said, achieving statistical significance on reduction in opioid use (78%) and reduction in pain scores, at 180.8 versus 209.3 in the bupivacaine group.
The drug also achieved statistical significance for the study’s key secondary endpoints. Patients in the EXPAREL arm required 77.6% fewer opioids through 72 hours than those in the bupivacaine arm, and time to first opioid rescue showed a significant difference between the EXPAREL group versus the bupivacaine group.