Pacira Pharmaceuticals has reported the results from a placebo-controlled, pivotal Phase III trial of Exparel (bupivacaine liposome injectable suspension), a non-opioid local analgesic for administration into a surgical site.
Exparel is an innovative product that combines bupivacaine with DepoFoam, providing analgesia with reduced opioid requirements for up to 72 hours.
The randomised, double-blind, and placebo-controlled multicentre study compared the magnitude and duration of postsurgical analgesia from a single dose of Exparel with a placebo administered intraoperatively via deep tissue infiltration, in patients undergoing a two- or three-column excisional haemorrhoidectomy.
The study reported that administration of Exparel resulted in a reduction in pain compared with the placebo at all times, including a 30% reduction in the cumulative pain score at 72 hours.
The trial’s primary efficacy endpoint was postsurgical pain control, measured by evaluating patients’ cumulative pain score, a measure of pain intensity over time, through 72 hours, and opioid use and patient satisfaction.
The median time to first opioid use was more than 12 times longer in the Exparel group compared to the placebo group, and 95% of patients in the Exparel group were satisfied or extremely satisfied with their postsurgical analgesia at 72 hours compared to 73% of patients in the placebo group.
The trial also demonstrated that patients given Exparel consumed 45% fewer opioids than patients administered placebo.
Mount Sinai Medical Center, New York, US clinical professor of surgery Stephen Gorfine said the study results show that Exparel provides considerable postsurgical pain control with a decreased reliance on opioids and improved patient satisfaction compared with a placebo in a soft tissue surgical model.
"Our study showed that Exparel is a useful therapeutic option for postsurgical pain management that may reduce the use of opioids, which are associated with a range of unwanted and potentially severe side effects," Gorfine said.