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  • EXPAEL In Femoral Nerve Block Showing 72 Hour Pain Reduction



    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


    Read more here: http://www.heraldonline.com/2014/04/...#storylink=cpy

    PARSIPPANY, N.J. & CHICAGO
    Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced additional Phase 3 data supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) to achieve a femoral nerve block in patients undergoing total knee arthroplasty. The Company previously announced results of the primary efficacy endpoint, a statistically significant reduction in cumulative pain scores over 72 hours compared to placebo (P<0.0001). Secondary endpoints presented at the 39th Annual Meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) found that a higher percentage of patients who received EXPAREL were pain-free, consumed fewer opioids and reported higher satisfaction with their pain control.

    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.
    About Pacira
    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® (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®, 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.
    About EXPAREL®
    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 athttp://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.

    Read more here: http://www.heraldonline.com/2014/04/...#storylink=cpy
    Comments 3 Comments
    1. BuckeyeRN's Avatar
      BuckeyeRN -
      Intriguing.....I have wondered about this also for shoulders with ISB. My main concern with it for femorals was loss of motor function which would upset the surgeon.

      Definitely has the potential to be game changing.
    1. gaspass3's Avatar
      gaspass3 -
      Quote Originally Posted by BuckeyeRN View Post
      Intriguing.....I have wondered about this also for shoulders with ISB. My main concern with it for femorals was loss of motor function which would upset the surgeon.

      Definitely has the potential to be game changing.
      If this is delaying ambulation even a little, it would be a no go at my hospital. That is almost TOO long.

      Sent from my SAMSUNG-SM-N900A using Tapatalk
    1. schlony's Avatar
      schlony -
      As of now, Exparel is only FDA okayed for local infiltration. Is anyone using in for actual nerve blocks?