Pacira Pharmaceuticals, Inc. has announced results from a pooled analysis of IMPROVE, a series of open-label prospective, Phase 4 clinical studies designed to compare postsurgical narcotic use and health economic outcomes associated with EXPAREL® (bupivacaine liposome injectable suspension) as the foundation of a multimodal analgesic regimen versus a standard opioid-based pain management regimen. The analysis, published in this month's issue of the Journal of Pain Research, concluded that in comparison to the current standard of care, an EXPAREL-based multimodal regimen was associated with significant reductions in opioid consumption, incidence of opioid-related adverse events (ORAEs), length of hospital stay and total hospital costs.
The IMPROVE studies were conducted at 13 centers and evaluated a total of 191 patients, who underwent three frequently performed gastrointestinal surgeries: open colectomy, laparoscopic colectomy and ileostomy reversal. Of the 191 patients included in the analysis, 105 received an opioid-based analgesic regimen via intravenous (IV) patient-controlled analgesia (PCA), while 86 patients received an EXPAREL-based multimodal pain management regimen. According to the analysis, the EXPAREL group was associated with:
- A 60 percent reduction in total narcotic consumption (38 mg versus 96 mg in the IV opioid PCA group; P
- A 67 percent reduction in incidence of ORAEs (9 percent versus 27 percent in the IV opioid PCA group; P=0.0027)
- A 1.4 day reduction in median length of hospital stay (2.9 versus 4.3 days in the IV opioid PCA group; P
- A $2,455 savings in mean per-patient hospitalization costs ($8,271 versus $10,726 for the IV opioid PCA group; P = 0.0109)
"EXPAREL has the potential to change the postsurgical pain management landscape where narcotics have long been the only effective option, despite their inherent risks," said Stephen M. Cohen, MD, MBA, FACS, FASCRS, Atlanta Colon and Rectal Surgery, PC, and the lead author of the IMPROVE manuscript. "Building on a solid body of safety and efficacy data, the IMPROVE studies provide quantitative, comparative data on the positive impact of EXPAREL on important pharmacoeconomic benefit measures such as narcotic usage, hospital stay and overall hospital cost. Based on our conclusions, clinicians and hospital administrators should consider transitioning toward narcotic-sparing regimens with EXPAREL as the mainstay for therapy."
"The completion of our IMPROVE Phase 4 program marks an important milestone for the company and EXPAREL," added Dave Stack, president, chief executive officer and chairman of Pacira. "Demonstrating the measurable value of EXPAREL to patients and the healthcare system, both independently and in comparison to the standard narcotic-based analgesia, has been our core focus since launch and continues to be an integral lever to increase adoption. In fact, we're increasingly hearing from surgeons across various specialties collecting their own outcomes data which, similar to IMPROVE, shows a quantifiable impact of replacing narcotics to improve patient care, patient satisfaction and hospital economics."