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news.Pacira Pharmaceuticals' Exparel (bupivacaine liposome injectable suspension), a non-opioid local analgesic, for administration into the surgical site to produce postsurgical analgesia has reported pain reduction in a pivotal Phase 3 trial.
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Exparel combines bupivacaine with DepoFoam, a proven product delivery technology that delivers bupivacaine for an extended period of time, providing analgesia with reduced opioid requirements for up to 72 hours.
The multicenter randomized double-blind placebo-controlled study compared the magnitude and duration of postsurgical analgesia from a single dose of Exparel over placebo administered intraoperatively via deep tissue infiltration in patients undergoing a two- or three-column excisional hemorrhoidectomy.
The study reported that patients treated with Exparel resulted in a significant reduction in pain compared to placebo at all time points, including a 30% reduction in the cumulative pain score at 72 hours.
In the trial, the median time to first opioid use was 12 times longer in the Exparel group over placebo group, and 95% of patients in the Exparel group showed satisfaction when compared to 73% of patients in the placebo group.
Mount Sinai Medical Center, New York, US clinical professor of surgery Stephen Gorfine said Exparel enables significant postsurgical pain control with a reduced reliance on opioids and improved patient satisfaction compared to 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 added.