Pacira Announces Data Reinforcing Benefits of EXPAREL for Postsurgical Pain Control Following Total Hip and Knee Replacement Surgery

Pacira Pharmaceuticals, Inc.

today announced data demonstrating the benefits associated with the use of EXPAREL® (bupivacaine liposome injectable suspension) in a study of over 2,200 hip and knee replacement patients. According to the analysis, patients treated with EXPAREL reported significantly lower pain scores, were more likely to report having "zero pain" during their hospital stay and were associated with lower hospital costs than patients treated with the standard pain management regimen. The results were presented at an oral podium session at the 2015 annual meeting of the American Academy of Orthopedic Surgeons (AAOS) in Las Vegas March 24-28. More than 1.1 million total joint arthroplasties (commonly known as joint replacements) are performed annually in the United States,1 and postsurgical pain is typically managed with continuous regional nerve blocks and systemic opioids, which can be associated with unwanted side effects such as leg weakness and sedation, both of which increase the risk of falls. Periarticular injections (PAI) of pain medications have been shown to be an effective approach to control postsurgical pain while improving function and reducing the need for opioids. This analysis, which builds on a smaller subset of data presented at the 2014 AAOS annual meeting, evaluated 2,248 patients who underwent hip or knee arthroplasty and received a standard well-established multimodal regimen including PAI. Half of the patients received PAI with bupivacaine HCl, with or without ketorolac, and morphine, while the other half received PAI with EXPAREL. The primary outcomes measured were Visual Analog Scale (VAS) pain scores and the percent of VAS pain scores that were 0, meaning patients reported "no pain." In addition, length of stay, patient-reported satisfaction and per patient costs for supplies and pharmaceuticals were compared between the two treatment groups. Key findings associated with the use of EXPAREL included: Significantly lower pain scores (1.98 vs. 2.43, P<0.0001) Greater percentage of patients reporting "no pain" for hip (57.3% vs. 43.4%, P<0.0001) and for knee (47.2% vs. 42.1%, P <0.0001) Decreased length of stay for patients undergoing knee replacement (2.40 days vs. 2.69 days, P<0.001) Improved Press Ganey overall satisfaction (98.3% vs. 96.7%; P=0.0221) Average cost savings of $1,246 per patient, which resulted in an overall hospital savings of over $1.5 million, predominately attributed to eliminating the need for femoral nerve catheters, knee immobilizers and patient controlled analgesia (PCA) pumps to deliver IV opioids "Getting patients on their feet and moving is critical to optimizing long-term treatment outcomes after hip or knee surgery, and the ability to provide a single-dose long-lasting alternative to opioids and catheter-based regional nerve blocks—which can negatively impact ambulation and the patient recovery experience—is a major advantage for orthopedic patients," said John Barrington, M.D., orthopedic surgeon at Texas Center for Joint Replacement in Plano, TX. "Our analysis found that the use of EXPAREL can improve both pain control and patient satisfaction, while resulting in a meaningful cost savings per patient." "Dr. Barrington's data reinforces a large and growing body of clinical and real-world evidence supporting the utility of EXPAREL in joint replacement procedures," said Dave Stack, president, chief executive officer, chairman and director of Pacira. "In addition to improving key outcomes such as pain scores, length of stay and costs of care as this study showed, EXPAREL provides the added value of reducing the need for opioids and thereby minimizing unnecessary exposure to potentially serious downstream consequences like long-term use and abuse, especially important in the context of the opioid epidemic in the United States today." EXPAREL is currently 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. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com. 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. Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.