Data Presented at the Annual Meeting of the American Association of Hip and Knee Surgeons
PARSIPPANY, N.J., Nov. 06, 2015 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced positive data on the use of EXPAREL® (bupivacaine liposome injectable suspension) as a postsurgical analgesic following total knee replacement surgery. The study, which compared the use of EXPAREL infiltration to the standard of care in 1,110 patients, found that EXPAREL was associated with significant improvements in a variety of patient and health economic outcomes, including opioid use, hospital stay and readmission rate. The poster, titled Liposomal Bupivacaine versus Femoral Nerve Block for Post-operative Pain Control following Total Knee Arthroplasty, was presented today at the 25th annual meeting of the American Association of Hip and Knee Surgeons being held in Dallas on Nov. 6-8, 2015.
In the study, patients who underwent total knee arthroplasty (TKA) received identical pre-, intra- and postoperative pain management protocols, with the exception of 527 patients who received EXPAREL infiltration in place of a femoral nerve block ([FNB] n=583). The poster’s authors compared several patient and cost-related outcomes. Opioid use during hospitalization was significantly reduced in the EXPAREL group, other key findings included:
- Shorter hospital length of stay (2.93 days for the EXPAREL group vs. 3.19 days for FNB group, P<0.001)
- Lower 30-day all-cause readmission rate (0.95% for the EXPAREL group vs. 2.57% for the FNB group, P=0.041)
- Reduced inpatient fall rate (0.56% for the EXPAREL group vs. 2.11% for the FNB group, P=0.03)
- Increased rate of discharge to home (77.8% for the EXPAREL group vs. 72.21% for the FNB group, P=0.032)
“Based on our analysis, incorporating liposomal bupivacaine into the postsurgical analgesic protocol following total knee arthroplasty has significant and quantifiable benefits to both the patient and the institution,” said Richard Iorio, M.D., professor of orthopaedic surgery at NYU School of Medicine. “The measurable opioid-sparing effect of this new regimen has enabled us to virtually eliminate intravenous patient-controlled analgesia, or PCA, devices from the standard of care in total joint arthroplasty patients, without compromising patient comfort. In addition, we found that the incremental cost of adding this new modality was offset by meaningful savings from shorter anesthesia induction time in the operating room, shorter hospital stays and lower rates of 30-day readmission.”
“Dr. Iorio’s analysis is a best-in-class example of how an institution can effectively evaluate the value of a new pain modality, such as EXPAREL,” said Dave Stack, chief executive officer and chairman of Pacira. “As the data shows, the benefits of EXPAREL extend well beyond effective pain control to a host of other recovery-related outcomes such as opioid burden, hospital stay and time to rehabilitation, which can collectively impact not only institutional costs, but also patient satisfaction.”
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
EXPAREL (bupivacaine liposome injectable suspension) 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 score with up to 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.
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), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, 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.
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.
Forward Looking Statements
Any statements in this press release about our future expectations, plans, outlook and prospects, 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 and opportunities, including nerve block, oral surgery and chronic pain, as well as pediatrics, and the timing and success of any related clinical trials; the related timing and success of a United States Food and Drug Administration supplemental New Drug Application; the adverse effects and impacts of FDA warning letters; the outcome of the U.S. Department of Justice inquiry; the outcome of our lawsuit against the FDA; 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.
Pacira Pharmaceuticals, Inc.
Jessica Cho, (973) 254-3574
Pure Communications, Inc.
Dan Budwick, (973) 271-6085
Pacira Pharmaceuticals, Inc