Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced the publication of data from a placebo-controlled, pivotal Phase 3 trial of EXPAREL™ (bupivacaine liposome injectable suspension), a non-opioid local analgesic that was recently approved by the U.S. Food and Drug Administration (FDA) for administration into the surgical site to produce postsurgical analgesia. The results, which demonstrate statistically significantly lower pain scores and decreased opioid requirements for up to 72 hours with EXPAREL, were published in the December print edition of the peer-reviewed journal Diseases of the Colon & Rectum.
The multicenter, randomized, double-blind, placebo-controlled study compared the magnitude and duration of postsurgical analgesia from a single dose of EXPAREL with that of placebo administered intraoperatively via deep tissue infiltration in patients undergoing a two- or three-column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique. Patients in both populations who experienced inadequate pain control were eligible to receive opioids for rescue pain relief.
The primary efficacy endpoint was postsurgical pain control, measured by assessing patients' cumulative pain score, a measure of pain intensity over time, through 72 hours. Opioid use and patient satisfaction were also investigated.
Key findings included:
- Administration of EXPAREL resulted in a statistically significant reduction in pain compared to placebo at all time points, including a 30 percent reduction in the cumulative pain score at 72 hours (P<0.0001).
- The median time to first opioid use was more than 12 times longer in the EXPAREL group compared to the placebo group (14.3 hours vs 1.2 hours, respectively; P<0.0001).
- Patients administered EXPAREL consumed 45 percent fewer opioids than patients administered placebo.
- Ninety-five percent of patients in the EXPAREL group were "satisfied" or "extremely satisfied" with their postsurgical analgesia at 72 hours compared to 73 percent of patients in the placebo group.
The overall incidence of treatment-emergent adverse events in this study was similar between the EXPAREL and placebo groups, with the majority of adverse events being mild in severity. The most frequently reported treatment-emergent adverse events were anal hemorrhage and painful defecation.
"The results of this trial demonstrate that EXPAREL provides significant postsurgical pain control with a decreased reliance on opioids and improved patient satisfaction compared to placebo in a soft tissue surgical model," said Stephen R. Gorfine, M.D., lead author of the manuscript and clinical professor of surgery at Mount Sinai Medical Center, New York, NY. "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."
"We are pleased to have the efficacy and safety data from this pivotal study of EXPAREL published and available in the public domain," said Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. "With our recent FDA approval, this manuscript provides further support for the important role EXPAREL can play in optimizing postsurgical pain management."
How bacteria trigger colon cancer