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Pacira Posts Positive Post-Approval Results

Exparel excels against IV PCA opioid in laparoscopic colectomy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Pacira Pharmaceuticals posted results from its Phase IV study of Exparel in laparoscopic colectomy. The study, known as IMPROVE, represents a series of open-label prospective Phase 4 trials to assess the differences in postsurgical opioid use and health economic outcomes between patients receiving  Exparel (bupivacaine liposome injectable suspension) as the foundation of a multimodal analgesic regimen versus a standard opioid-based regimen for postsurgical pain control. Exparel is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.

The study evaluated 82 patients who underwent laparoscopic colectomy, a minimally invasive surgery to remove all or part of the colon using several small incisions in the abdomen. Compared to patients in the standard opioid-based treatment arm, who received intravenous (IV) opioids via patient-controlled analgesia (PCA) devices, patients undergoing the same procedure and receiving an Exparel-based multimodal regimen experienced:

  • A 64 mg reduction in mean opioid consumption (32 mg in the Exparel group compared with 96 mg in the IV opioid-based PCA group)
  • A 1-day reduction in median length of hospital stay (3.0 days in the Exparel group compared with 4.0 days in the IV opioid-based PCA group)
  • Significantly fewer opioid-related adverse events (ORAEs) (8% of patients in the Exparel group experienced ORAEs, compared with 41% of patients in the IV opioid-based PCA group)
  • A $1,784 reduction in mean hospitalization costs ($11,234 in the Exparel group compared with $13,018 in the IV opioid-based PCA group)

This study was conducted at six sites across the U.S.; 26 patients were treated with an Exparel-based multimodal treatment regimen, while 56 patients received opioid-based IV PCA.

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