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EXPAREL Use in Femoral Nerve Block for Total Knee Arthroplasty Further Supported by Additional Data from Phase 3 Pivotal Study, sNDA Submission Planned for Second Quarter 2014
Data Presented at the 39th Annual Meeting of
This randomized, double blind, placebo controlled study evaluated 278 patients who received either a femoral nerve block with EXPAREL or a placebo. A femoral nerve block provides pain control for the anterior (front) of the knee; in this trial there was no pain medication provided at the time of surgery for the posterior (back) of the knee, which explains the lack of a significant difference in time to first opioid rescue between the two study groups. In addition to pain scores through 72 hours, investigators also measured total opioid consumption through 72 hours, time to first opioid rescue, patient satisfaction with pain control and safety.
The key findings are summarized below:
- A 24 percent reduction in total opioid use in the EXPAREL group (P<0.05); there was no significant difference between groups in the time to first opioid rescue
- A greater number of patients who were “extremely satisfied” with pain control in the EXPAREL group vs. placebo group at day 7 (55 percent vs. 43 percent) and day 30 (65 percent vs. 50 percent)
- A statistically significantly higher percentage of “pain-free” patients in the EXPAREL group (~50 percent vs. 40 percent for placebo group at 60 hours; [P<0.05])
- Safety was comparable between the EXPAREL and placebo groups, with similar numbers of patients displaying a normal ability to do a 20-meter walk test and similar physician satisfaction with return of motor function
Five additional studies evaluating the use of EXPAREL in transversus abdominis plane infiltration and nerve block will also be presented at the ASRA meeting.
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