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news.Pacira Pharmaceuticals' multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 3 study evaluating Exparel met primary endpoint.
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Exparel is Pacira’s proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam, both of which are currently used separately in FDA-approved products.
The study results showed less pain and reduction in opioid use for 72 hours following a single injection of Exparel at the end of the surgical procedure.
Exparel demonstrated reduction in cumulative pain score in patients compared to placebo.
In addition, the study showed that Exparel was well tolerated, with the incidence of adverse events (AEs) similar to placebo.
Pacira Pharma president and CEO David Stack said these Phase 3 data demonstrate that the median time to first opioid rescue for patients treated with Exparel following hemorrhoidectomy was significantly longer than those treated with placebo.
"We believe that these data coupled with our positive Phase 3 data from our bunionectomy trial will help support the potential utility of Exparel in a clinical setting and build important mindshare among key opinion leaders," Stack said.