Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) 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
"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.About Pacira Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's flagship product, EXPAREL ® (bupivacaine liposome injectable suspension), a non-opioid local analgesic for postsurgical pain control, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam ®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com. Forward Looking Statements Any statements in this press release about our future expectations, plans, outlook and prospects, including statements about our expected revenues, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications, including nerve block, oral surgery and chronic pain, as well as pediatrics; the related timing and success of a United States Food and Drug Administration supplemental New Drug Application; our receipt of FDA approval of our nerve block indication; the adverse effects and impacts of FDA warning letters; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical studies in support of an existing or potential DepoFoam-based product; our plans to continue to manufacture and provide support services for our commercial partners who have licensed DepoCyt(e); our commercialization and marketing capabilities; our and Patheon UK Limited's ability to successfully and timely construct dedicated EXPAREL manufacturing suites; and other factors discussed in the "Risk Factors" of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2014, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. References
1 Hall MJ, DeFrances CJ, Williams SN, Golosinskiy A, Schwartzman A. A National Hospital Discharge Survery: 2007 summary. A qualitative and systematic review of the literature. The Journal of Bone and Joint Surgery. American volume. May 2004; 86-A(5):963-974.