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:5/25/2016)... PARIS , May 25,2016 ... with the near-infrared Cellvizio platform for urological and ... MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary ... important regulatory milestone in the US with the ... Food and Drug Administration (FDA). This new FDA ...
    (Date:5/25/2016)... GERMANTOWN, Maryland , May 25, ... Therawis bedient dringenden Bedarf ... QIAGEN N.V. (NASDAQ: QGEN ; ... Lizenz- und Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur ... eingegangen zu sein. Ein erstes Projekt wird die ...
    (Date:5/25/2016)...  Zymo Research Corp. announced today the final ... that help researchers obtain the most accurate and ... rapid growth of the study of microbiomes has ... methods to improve the reproducibility and quality of ... every step of the measurement process including collection ...
    Breaking Medicine Technology:
    (Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the unofficial start ... is sharing tips to make sure your family and vehicle are ready to hit ... there may be 439 deaths and an additional 50,500 serious injuries from motor vehicle ...
    (Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... North ... May 13 at Blackhorse Golf Club in Cypress. With the help of community partners, ... that restores, empowers, and renews hope for wounded service members and their families through ...
    (Date:5/26/2016)... Scotch Plains, NJ (PRWEB) , ... May 26, ... ... year being recognized as an NJ Top Doc! Along with his wonderful accolades ... to excellence in podiatry. Congratulations, Dr. Batelli! , Dr. Eugene Batelli is ...
    (Date:5/26/2016)... ... , ... On May 23rd during the National Eye Institute’s “Healthy Vision Month”, ... was honored by Ashram, Inc. as the world’s foremost water visionary. , “Sharon Kleyne ... of the Nile to fill their red clay pots with life-sustaining water.” Said Ashram ...
    (Date:5/26/2016)... ... May 26, 2016 , ... ... Morrow-Fox . With over 20 years of experience in leading technology and human ... several years of university teaching, Morrow-Fox will be featured on Metcalf’s VoiceAmerica ...
    Breaking Medicine News(10 mins):