Navigation Links
Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data to Be Presented at Upcoming Medical Meetings
Date:10/11/2011

a announced that its New Drug Application (NDA) for EXPAREL (bupivacaine liposome extended-release injectable suspension), the company's most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive Phase 3 clinical development for postsurgical 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.

About EXPAREL™

EXPAREL (bupivacaine liposome extended-release injectable suspension) 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. Market data indicate that there is an unmet medical need for a longer-acting anesthetic/analgesic for postsurgical pain management. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and suggest statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggest that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. 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.  

<
'/>"/>
SOURCE Pacira Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Pacira Pharmaceuticals, Inc. Adds Experienced Physician Dr. David St. Peter to Leadership Team
2. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Second Quarter 2008 Financial Results on Monday, August 11, at 8:30 A.M. EDT
3. VioQuest Pharmaceuticals, Inc Q2/08 Review Issued by Scimitar Equity, LLC
4. Rib-X Pharmaceuticals, Inc. Announces Formation of Clinical Advisory Board
5. Transcept Pharmaceuticals, Inc. to Present at the Natixis Bleichroeder Second Annual Hidden Gems Conference
6. Transdel Pharmaceuticals, Inc. Retains The Investor Relations Group
7. Chemical Engineering Conference Highlights Energy, Biomedicine, Pharmaceuticals, Sustainability and Centennial
8. Alseres Pharmaceuticals, Inc. Reports Third Quarter 2008 Operational and Financial Results
9. Johnson & Johnson Completes Acquisition of Omrix Biopharmaceuticals, Inc.
10. Alseres Pharmaceuticals, Inc. Announces $1 Million Financing
11. Angiotech Pharmaceuticals, Inc. announces new Senior Secured Term Loan and Credit Facilities
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... BETHESDA, Md. , Jan. 14, 2014  Organovo ... institutes from the National Institutes of Health (NIH) to ... more effective treatments to patients on a faster timeline. ... Translational Sciences (NCATS) and the National Eye Institute (NEI) ...
(Date:1/14/2014)... In recent years, growing suspicion about the pharmaceutical ... and promotion has led to unprecedented levels of public ... about the insidious impact of commercialization of research, has ... the world’s biggest pharmas for illegal marketing activities, allegations ...
(Date:1/14/2014)... 2014 Global Record Systems, LLC, ... technology solutions for patients, physicians, the biopharmaceutical industry, ... today the signing of a three-year Research Collaboration ... Administration (FDA). This initiative is designed to ...
(Date:1/14/2014)... and Cardiff, UK (PRWEB) January 13, 2014 ... development leader with more than 20 years in the ... optics and photonics . Hainsey will serve as the ... to have Dr. Hainsey join SPIE as our Technology ...
Breaking Biology Technology:Organovo Announces Collaboration with National Institutes of Health 2Organovo Announces Collaboration with National Institutes of Health 3The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 2The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services 3Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information 2Photonics R&D Leader Bob Hainsey Joins SPIE Technical Staff 2
... Solutions, LLC, Santa Clara, CA, a manufacturer of ... applications, announced the release of TruTorr(TM), a single-use ... containers, in order to prevent overpressure damage, at ... TruTorr system consists of a disposable pressure sensor, ...
... option for millions of Americans with debilitating lung ... (NYSE: AZN ) today announced that ... approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for ... in patients with chronic obstructive pulmonary disease (COPD), ...
... Is Just What Diabetics Have Been Waiting For. The Sleek, Bold ... By Storm. , ... Greenville, SC (PRWEB) February 27, 2009 -- For ... that is both functional and attractive. In recent years, many companies ...
Cached Biology Technology:Finesse Announces TruTorr(TM) Single-Use Pressure Sensor 2FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 2FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 3FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 4FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 5FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD) 6Home Delivery Medical Offers New Glucose Meter With State-Of-The-Art Technology 2Home Delivery Medical Offers New Glucose Meter With State-Of-The-Art Technology 3
(Date:4/23/2014)... Putnam Valley, NY. (Apr. 23 2014) ... human neural stem cells (hNSCs) into the brains ... differentiation after 22 and 24 months found that ... months and did not cause tumors. , The ... of Cell Transplantation but is currently ...
(Date:4/23/2014)... trope that the likelihood of an accurate group decision ... hold up when a collective faces a variety of ... Instead, Princeton University researchers report that smaller groups actually ... may become excessively focused on only certain pieces of ... what is known about collective intelligence, or the "wisdom ...
(Date:4/23/2014)... a signing ceremony in Buenos Aires yesterday, Argentina ... an associate member state. The move strengthens the ... science communities. It grants Argentinian scientists access to ... beneficial collaborations. , "Ever since its inception, fostering ... have been at the core of EMBL,s mission," ...
Breaking Biology News(10 mins):Study finds long-term survival of human neural stem cells transplanted into primate brain 2Too many chefs: Smaller groups exhibit more accurate decision-making 2Too many chefs: Smaller groups exhibit more accurate decision-making 3
... OTO EXPO of the American Academy of Otolaryngology Head ... nose, and throat doctors in the world, will convene September ... scientific research sessions, 594 posters, and several hundred instruction course ... for journalists from around the world to cover breaking science ...
... 2010 - Eurofins MWG Operon, an expert in next generation ... GS Junior. The GS Junior is the optimum system for ... one eighth of the capacity of a GS FLX Titanium ... run. As a consequence, the GS Junior adds a higher ...
... This release is available in French ... high electrical conductivity that promise to revolutionize a wide range ... A team of McGill University researchers have now reported ... along one single conductive polymer molecule at a time, a ...
Cached Biology News:2010 AAO-HNSF miniseminars: Tuesday, Sept. 28, 2010 22010 AAO-HNSF miniseminars: Tuesday, Sept. 28, 2010 3Striding towards a new dawn for electronics 2