Data Presented at the Annual Meeting of the American Academy of Orthopaedic Surgeons
PARSIPPANY, N.J., March 01, 2016 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced results of new data showing that EXPAREL® (bupivacaine liposome injectable suspension) infiltration compared to a standard analgesic regimen in patients undergoing total knee arthroplasty (TKA) significantly decreased the length of hospital stay and increased the likelihood that a patient would be discharged to their home rather than a care facility when released from the hospital. The poster, which is authored by researchers from Philadelphia College of Osteopathic Medicine (PA), Sinai Hospital of Baltimore (MD) and Plano Orthopaedics Sports Medicine and Spine Center (TX), is being presented at the American Academy of Orthopaedic Surgeons (AAOS) 2016 Annual Meeting in Orlando March 1st – 5th.
“The results of this analysis are encouraging because they suggest that the use of EXPAREL not only allows us to get our patients up and out of the hospital sooner, but also increases the likelihood we can send them directly home,” said Michael Mont, M.D., director of the Center for Joint Preservation and Replacement at Sinai Hospital and an author on the poster. “The ability to recover at home, rather than in a short-term nursing facility or rehabilitation center, not only lends itself to favorable hospital economics, but also—importantly—toward a more comfortable patient recovery experience.”
In this retrospective analysis, which was supported by Pacira, researchers reviewed data from the Premier hospital discharge database in order to identify patients ages 18 and older who underwent an inpatient TKA procedure between July 1, 2013 and June 30, 2014. The analysis compared 94,828 patients who had received either a standard analgesic regimen (80,160) or EXPAREL (14,668).
Key findings for patients receiving EXPAREL compared to the standard analgesic modalities included:
- Nearly a half-day reduction in length of hospital stay (2.58 vs 2.98 days, respectively; p<0.001)
- More patients discharged directly to home rather than an interim care facility (73.2% vs 66.6%, respectively)
- A higher likelihood of being discharged home, according to a logistic regression analysis (OR=1.49 for patients in the EXPAREL group; p<0.001)
“Today’s dynamic healthcare environment of accountable care, bundled payments and patient satisfaction-driven reimbursement are evidence of the critical role of non-opioid options such as EXPAREL for postsurgical pain management,” said David Stack, chief executive officer and chairman of Pacira. “This analysis provides further evidence that the use of EXPAREL can have a substantial positive impact on patient outcomes while delivering strong value to the surgical community, hospital administrators and healthcare economics.”
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 score with a 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/hcp/pdf/EXPAREL_Prescribing_Information.pdf
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, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” 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, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; 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, 2015 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
Coyne Public Relations
Alyssa Schneider, 973-588-2270
Pacira Pharmaceuticals, Inc