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Pacira Pharmaceuticals Inc. Announces New Data on the Use of EXPAREL to Treat Postsurgical Pain Following Total Knee Arthroplasty
-- Data Presented at the 2014 Annual Meeting of the
“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
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.
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