Pacira Pharmaceuticals, Inc
. (NASDAQ: PCRX) today announced that results from the first IMPROVE study to complete its prospective Phase 4 clinical program were published in the online version of the
Journal of Pain Research
. The IMPROVE studies compare the difference in opioid use, total hospital cost and length of stay (LOS) between patients receiving
(bupivacaine liposome injectable suspension) as the foundation of an opioid-sparing multimodal regimen versus a standard opioid-based postsurgical pain management regimen.
Compared to patients undergoing open colectomy in the standard opioid-based treatment arm, patients undergoing the same procedure and receiving an EXPAREL-based multimodal regimen had:
- A 2.9-day reduction in median LOS (4.9 days in the hospital vs 2.0 days in the hospital, respectively; P=0.004)
- A $3,084 reduction in mean total hospital cost ($11,850 vs $8,766, respectively; P=0.027)
- A 58 mg reduction in mean opioid consumption (115 mg vs 57 mg, respectively; P=0.025)
“We are pleased that these data, which demonstrate a statistically significant reduction in extremely meaningful endpoints for both patient care and hospital economics are now available in the public domain,” said Dave Stack, President and CEO of Pacira. “Additional IMPROVE studies in laparoscopic colectomy and ileostomy reversal are nearing completion, and initial results seem to support what we have already seen in this IMPROVE study. We look forward to sharing those data in the near future, as we continue to demonstrate the significant impact EXPAREL may contribute to the management of postsurgical pain.”
Colorectal surgeon Stephen M. Cohen, MD, FACS, FASCRS at Southern Regional Medical Center in Atlanta, GA was the primary investigator in this study and performed all surgeries included in the study population. Eighteen patients were enrolled in the opioid-based group; 21 patients were enrolled in the EXPAREL-based multimodal regimen group. Topline findings from this IMPROVE study were
in October 2012.
The overall safety profile for EXPAREL was consistent with previous experiences in the Phase 3 program.