|Two New Studies Support Use of EXPAREL for Postsurgical Pain Management Following Total Joint Replacement|
Data Presented at 2014 Annual Meeting of the
More than 1 million patients have a hip or knee replaced each year in
“With the launch of HCAHPS2 and its accompanying mandate to correlate reimbursement rates with high patient satisfaction scores, optimizing postsurgical pain management is of increasing importance to clinicians, hospitals and payers,” said Dr. Barrington. “Our data found that an EXPAREL-based regimen not only improves pain scores and patient satisfaction, but also moves the needle on length of stay and hospital costs. From my perspective, these outcomes represent a win-win for all key stakeholders in the healthcare system -- hospitals looking to keep costs down without compromising care, payers looking to minimize incremental costs associated with complications that delay discharge, and most importantly, patients who want a comfortable recovery.”
A second study, a poster presented by Dr.
“Continuous femoral nerve block is an essential anesthetic tool, but in
its current form, it has limitations that may outweigh its benefits in
some patients. Apart from its residual effects on muscle strength and
range of motion, the ability to extend the duration of the nerve block
to cover the postsurgical period requires the continuous use of a
catheter placed into the surgical limb, which further restricts patient
mobility,” said Dr. Emerson, orthopedic surgeon at
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia, and is also being evaluated as a single administration anesthetic to achieve a nerve block.
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 analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. 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; 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; and other factors
discussed in the “Risk Factors” of our most recent Annual Report on Form
10-K for the fiscal year ended
2 The Hospital Consumer Assessment of Healthcare Providers
and Systems (HCAHPS) survey is the first national, standardized,
publicly reported survey measuring and comparing patients’ perceptions
of their hospital experiences, including satisfaction with pain control.