Pacira Pharmaceuticals Inc. Announces New Data on the Use of EXPAREL to Treat Postsurgical Pain Following Total Knee Arthroplasty
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced results of an independent, physician-initiated study designed to evaluate the difference in postsurgical pain and opioid consumption between patients who received EXPAREL versus a multi-drug analgesic cocktail for pain management following total knee arthroplasty (TKA). The data, presented at the annual meeting of the American Association of Hip and Knee Surgeons (AAHKS), found that patients treated with EXPAREL reported significantly lower patient-perceived pain scores and morphine sulfate equivalence consumption, and reported higher satisfaction with pain control and overall experience, compared with patients who received the multi-drug analgesic cocktail. The meeting is being held Nov. 6-9 at the Sheraton Dallas Hotel.
“A majority of patients who undergo total knee arthroplasty report dissatisfaction with overall pain control and side effects associated with narcotic medications, so there is clearly a need for a more effective and better-tolerated pain management option,” said Mark A. Snyder, M.D., director of the Orthopaedic Center of Excellence at Good Samaritan Hospital in Cincinnati. “Our study found that EXPAREL not only provided effective pain control, but also reduced opioid load and improved the patient’s overall experience. In addition, we found that EXPAREL eliminated the incidence of post-operative falls, a serious patient safety risk resulting from muscle weakness associated with nerve blocks and prolonged indwelling pain catheters, and confusion or disorientation caused by opioids.”
The double-blind, randomized clinical study evaluated 70 TKA patients who were randomly assigned to receive either a periarticular injection with EXPAREL or a multi-drug analgesic cocktail (ketorolac, morphine, epinephrine and ropivacaine) for postsurgical analgesia.
Key findings showed that compared to patients who received the multi-drug analgesic cocktail, patients who received EXPAREL reported:
- Significantly lower pain levels on post-op day one (p<.05) and post-op day two (p<.01)
- Significantly lower total morphine equivalency consumption in the PACU (p<.01) and by post-op day two (p<.01)
- Higher satisfaction in pain control (p<.001) and overall experience (p<.01)
- Significantly fewer adverse events (p<.01)
“The patient-perceived pain scores and high satisfaction ratings we observed suggest that EXPAREL may be a comparably effective, yet far better tolerated pain management solution than continuous femoral nerve blocks, which require catheters to deliver extended analgesia,” added Dr. Snyder. “While larger studies are needed to drive a shift in current practice guidelines, our data and previously reported physician-led studies indicate that EXPAREL should play a vital role in the pain management paradigm for orthopedic procedures.”
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
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 current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL(R) (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam(R), a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.
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 significant reductions in cumulative pain scores with a 45% 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.
Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about our plans and expectations regarding EXPAREL, and other statements containing the words “believes,” “anticipates,” “plans,” “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 indications of EXPAREL, including for nerve block and the related timing and success of an sNDA; 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’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, 2013, 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. 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.
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