Navigation Links
Pacira Pharmaceuticals Presents New Data from EXPAREL Phase 3 Study at Orthopaedic Research Society's 57th Annual Meeting
Date:1/13/2011

PARSIPPANY, N.J., Jan. 13, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that new data from its Phase 3 bunionectomy study to evaluate the efficacy and safety of the intraoperative administration of EXPAREL™ (bupivacaine extended-release liposome injection) is being presented in a poster session (number AAOS7) at the 57th Annual Meeting of the Orthopaedic Research Society held from January 13-16, 2011 in Long Beach, California. Study results from this multicenter, randomized, double-blind, parallel-group, placebo-controlled bunionectomy trial demonstrate that the median time to first use of opioid rescue medication was 7.2 hours for patients treated with EXPAREL compared with 4.3 hours for patients treated with placebo (p<0.0001).

The Phase 3 trial studied 193 subjects in four U.S. centers to determine the safety and efficacy of a single administration of EXPAREL for prolonged postoperative analgesia in subjects undergoing first metatarsal osteotomy (bunionectomy).

Previously disclosed Phase 3 findings in this study showed EXPAREL met its primary endpoint, with a statistically significant reduction in area under the curve analysis (AUC) of the pain intensity numeric rating scale (NRS) scores in subjects receiving EXPAREL compared with placebo (p=0.0005) over the first 24 hours following surgery. EXPAREL is a novel long-acting, sustained-release analgesic formulation of bupivacaine HCl. Bupivacaine HCl is widely used for treating postsurgical pain.

Additional key findings from the Phase 3 study being presented include:

  • A larger percentage of patients treated with EXPAREL avoided opioid rescue medication during the first 24 hours after surgery compared to placebo (7% vs. 1%; p<0.05);
  • Statistically, significantly more patients treated with EXPAREL were pain-free at 2, 4, 8 and 48 hours compared to placebo (p<0.05);
  • Statistically, significantly less opioids were consumed over the first 24 hours after surgery in the EXPAREL group (p=0.0077);
  • EXPAREL was well tolerated in patients who received postsurgical treatment for pain following bunionectomy; 59.8% of patients treated with EXPAREL experienced an adverse event compared to 67.7% of patients treated with placebo;
  • Most of the adverse events were not considered related to study drug and were mild or moderate in severity.

  • The full poster can be found on the Pacira website at www.pacira.com.  

    In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL had been accepted for filing by the U.S. Food and Drug Administration (FDA). Pacira submitted the EXPAREL NDA in September 2010 for the initial indication of postsurgical analgesia by local administration. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 28, 2011 for the review of the EXPAREL NDA.

    About EXPAREL™EXPAREL is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam®, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and demonstrate statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data has also demonstrated that EXPAREL provides analgesia for up to 72 hours post-surgery compared with 7 hours or less for bupivacaine. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.  

    About PaciraPacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, commercialization and manufacture of novel pharmaceutical products, based on its proprietary DepoFoam® drug delivery technology, for use in hospitals and ambulatory surgery centers. The company's most advanced product candidate, EXPAREL™, a bupivacaine-based product, has completed Phase 3 clinical development for postoperative analgesia by infiltration. EXPAREL consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. Additional information about Pacira is available at www.pacira.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor shall there be any sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.Contacts:James S. Scibetta, CFO, Pacira Pharmaceuticals, Inc.973-254-3560Jennifer Beugelmans, Investor Relations, Pure Communications Inc.646-596-7473
    '/>"/>

    SOURCE Pacira Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Pacira Pharmaceuticals Announces FDA Acceptance of EXPAREL™ New Drug Application for Pain Management
    2. Phase III Studies of EXPAREL(TM) (DepoBupivacaine) from Pacira Complete Enrollment
    3. Positive Phase II Study of Paciras EXPAREL(TM) (DepoBupivacaine) in Hernia Repair Presented at the Postgraduate Assembly in Anesthesiology (PGA)
    4. Positive Phase II Study of Paciras EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress
    5. Reportlinker Adds Watson Pharmaceuticals Inc.: PharmaVitae Profile
    6. Reportlinker Adds OTC Pharmaceuticals: Global Industry Almanac
    7. ADVENTRX Pharmaceuticals Announces Closing of $22.5 Million Financing
    8. Anadys Pharmaceuticals to Present at the J.P. Morgan Healthcare Conference
    9. Optimer Pharmaceuticals Appoints Hank McKinnell to Its Board of Directors
    10. Topaz Pharmaceuticals Names Dr. Mark Strobeck Chief Business Officer
    11. Optimer Pharmaceuticals Announces Key Additions to Management Team
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:2/12/2016)... Carolina , 12 februari 2016 /PRNewswire/ ... (AAI/CML), een toonaangevende leverancier van productie en ... biotechnologische industrieën, kondigt vandaag een uitbreiding aan ... op haar locatie in Charleston, ... heeft geleid tot meerdere recente investeringen. ...
    (Date:2/11/2016)... Feb. 11, 2016 The primary goal of ... adoption patterns on the usage of liquid biopsy. Key ... - Timeframe of liquid biopsy adoption amidst ... and Evs—by organization type - Sample inflow to conduct ... saliva, stool, serum, and so on. - Correlation analysis ...
    (Date:2/11/2016)... 2016  Walgreens has committed to provide drug disposal ... Washington, D.C. as part of a program ... by shareholder advocacy organization As You Sow. Conrad ... people hold on to unneeded drugs because they lack easily ... --> Conrad MacKerron , Senior Vice President ...
    Breaking Medicine Technology:
    (Date:2/12/2016)... ... 12, 2016 , ... According to an article published February 4th ... significant portion of hernia repairs throughout the United States. Commenting on this article, Beverly ... that this trend has not only been expected, but it seems to be a ...
    (Date:2/12/2016)... ... , ... CDRH Enforcement Trends: , Back to the Future , Feb. 25, 2016 — 11:00 ... said, “Those who don’t learn from history are doomed to repeat it.” , An analysis ... this year. But that takes time. , Take a close look at the warning ...
    (Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... ... firm announced that nominations have closed for the ISE Southeast Awards 2016. Finalists ... be announced at the ISE® Southeast Executive Forum and Awards Gala on March ...
    (Date:2/12/2016)... ... February 12, 2016 , ... AssureVest Insurance Group, a locally ... a charity drive that will raise funds earmarked to purchase computers and software for ... School. , “My school is in a low-income area and has more than 60 ...
    (Date:2/12/2016)... ... February 12, 2016 , ... Donor Network West, the organ ... Nevada, announced a partnership with San Ramon Regional Medical Center. Under the collaboration, the ... as a way to accommodate a more certain time frame for donor families for ...
    Breaking Medicine News(10 mins):