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 EXPAREL® (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)
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 announced in October 2012. The overall safety profile for EXPAREL was consistent with previous experiences in the Phase 3 program.
"Having used EXPAREL in my open bowel resection cases for the last six months, I have seen first-hand the benefit of treating pain directly at the source," said Dr. Cohen. "My patients have excellent pain control both in the immediate postsurgical setting and for up to three days following their procedure. This pain control significantly reduces - and sometimes completely eliminates - the need for opioids. As we have seen in the IMPROVE trial, this can enhance patient recovery and lead to a substantial decrease in hospital length of stay."
EXPAREL® (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.