|View printer-friendly version|
|Pacira Announces Data Reinforcing Benefits of EXPAREL® for Postsurgical Pain Control Following Total Hip and Knee Replacement Surgery|
-- Results Presented at the 2015 Annual Meeting of the American
Academy of Orthopedic Surgeons Find Overall Hospital Cost Savings of
More than 1.1 million total joint arthroplasties (commonly known as
joint replacements) are performed annually in
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:
“Getting patients on their feet and moving is critical to optimizing
long-term treatment outcomes after hip or knee surgery, and the ability
to provide a single-dose long-lasting alternative to opioids and
catheter-based regional nerve blocks—which can negatively impact
ambulation and the patient recovery experience—is a major advantage for
orthopedic patients,” said
“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
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.
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
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.