Navigation Links
Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
Date:6/3/2008

SOUTH SAN FRANCISCO, Calif., June 3 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that the South Korea Food and Drug Administration has approved Anesiva's investigational new drug application for Adlea(TM), the company's long-acting, site specific, non-opioid drug candidate in Phase 3 clinical development for the management of acute pain following orthopedic surgery. Anesiva plans to initiate a Phase 2 clinical trial of Adlea in patients undergoing arthroscopic shoulder surgery in South Korea this summer.

"We selected South Korea for this Adlea clinical trial because the standards of care in orthopedic surgery and the professional training of its clinicians are similar to those in the United States," said John McLaughlin, chief executive officer. "An important difference from U.S. clinical practice is that arthroscopic shoulder surgery patients in South Korea are routinely admitted to the hospital for two or more days following surgery. This extended hospitalization period will enable us to conduct longer and more detailed post-surgical safety and efficacy analyses than would be practical in the United States."

The planned study is a multicenter, randomized, double-blind, placebo- controlled, two-stage exploratory study to evaluate the safety, tolerability, efficacy and pharmacokinetics of a single dose of Adlea compared to placebo administered at the conclusion of arthroscopic shoulder surgery. The trial is designed to enroll 74 patients.

Adlea is currently in two pivotal Phase 3 trials in the U.S.: one in total knee replacement surgeries and one in bunionectomy surgeries. Top-line data from both trials are expected by year-end 2008. An additional Phase 2 Adlea trial is in progress in total h
'/>"/>

SOURCE Anesiva, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics
2. Anesiva Announces Pivotal Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Total Knee Replacement
3. Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
4. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
5. Anesiva Defines Regulatory Pathway for Adlea with FDA
6. Anesiva Initiates Phase 2 Trial with Adlea(TM) for Pain Relief Following Total Hip Replacement Surgery
7. Anesiva Initiates New Phase 2 Trial of Adlea(TM) for Pain Relief Following Knee Replacement Surgery
8. Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
9. Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytrens Contracture
10. Trubion Announces Presentation of Positive TRU-016 Data at ASCO
11. Alliance Pharmaceutical Corp. Announces Approval of Proposed Actions at Annual Shareholders Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2014)...  Eli Lilly and Company (NYSE: ... study in genetically engineered mice examining combination therapy ... N3pG and beta-secretase inhibitor BACE (LY2811376). Data results ... removing clumps of amyloid-beta protein in the brain ... to Alzheimer,s disease (AD) – than use of ...
(Date:7/11/2014)... DUBLIN , July 11, 2014 ... the "Global and Chinese Medical X-ray Film Industry ... http://photos.prnewswire.com/prnh/20130307/600769 Global And ... professional and in-depth study on the current state of ... on the Chinese situation. The report provides a ...
(Date:7/11/2014)... On Thursday, July 10, 2014, the ... Industrial Average finished the day 0.42% lower at 16,915.07, and ... were broad based as eight out of ten sectors ended ... Index ended the day at 711.88, down 0.02%, while the ... has initiated coverage on the following equities: Covidien PLC (NYSE: ...
Breaking Medicine Technology:New Data Shows Combination Therapy is More Effective than Monotherapy in Removing Beta-Amyloid Plaques from the Brains of Mice 2New Data Shows Combination Therapy is More Effective than Monotherapy in Removing Beta-Amyloid Plaques from the Brains of Mice 3Global and Chinese Medical X-ray Film Industry Report 2014 2Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 2Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 3Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 4
... 2011 Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX ) ... with management to discuss first quarter 2011 financial results, as ... 4, 2011, at 8:00 a.m. Eastern Time (5:00 a.m. Pacific ... first quarter ended March 31, 2011 will be released earlier ...
... iMD Companies (ICBU.PK) is pleased to announce that is ... Mobile Imaging LLC, which increases and diversifies the Company,s ... with cash and restricted stock and is accretive to ... www.OMIAZ.com .   OMI is currently running at ...
Cached Medicine Technology:Onyx Pharmaceuticals Announces First Quarter 2011 Financial Results Teleconference and Webcast 2iMD Companies, Inc. Acquires OMI LLC and Files Financials for 2010 2iMD Companies, Inc. Acquires OMI LLC and Files Financials for 2010 3
(Date:7/13/2014)... 2014 Ticket Down is a ... . For the fifth straight year (and second under ... held at American stadiums this summer. The tournament features eight ... The eight teams are split into two groups of four ... two teams will compete to become champion. One team that ...
(Date:7/13/2014)... Nature Genetics identifies a novel genetic ... eosinophillic esophagitis (EoE), opening up potential new therapeutic ... , EoE is a chronic inflammatory disorder ... allergic hypersensitivity to certain foods and an over-accumulation ... eosinophils (part of the body,s immune system). EoE ...
(Date:7/13/2014)... Recently, MillionaireCasket.com, a well-known casket manufacturer from China, has ... the company’s chief executive officer has announced a new promotion ... offered at discounted prices, from 15 to 26 percent off. ... in huge demand in the current market. We are excited ... a lot of high quality products for sale. Many of ...
(Date:7/13/2014)... 13, 2014 Micro irrigation systems are ... water dispersal as wells as to maintain soil quality. ... projected to become a dominant revenue generator for manufacturers ... to reduce resource costs has led to the adoption ... and has further caused massive demand for micro irrigation ...
(Date:7/13/2014)... Fuel additives are chemicals, which are added ... kerosene, and so on, in order to enhance their ... corrosion effects caused by fuels and improving the combustion ... provide economies of scale in the long run, but, ... of the fuel products. , The various fuel additive ...
Breaking Medicine News(10 mins):Health News:AS Roma vs Real Madrid Tickets in Dallas at Cotton Bowl: Ticket Down Slashes Ticket Prices for Real Madrid vs AS Roma Guinness International Champions Cup Match 2Health News:AS Roma vs Real Madrid Tickets in Dallas at Cotton Bowl: Ticket Down Slashes Ticket Prices for Real Madrid vs AS Roma Guinness International Champions Cup Match 3Health News:Study finds cause of mysterious food allergy, suggests new treatment strategy 2Health News:Study finds cause of mysterious food allergy, suggests new treatment strategy 3Health News:Cheap Oak Caskets Recently Unveiled By China Casket Manufacturer MillionaireCasket.com 2Health News:Agricultural Micro Irrigation System Market is Expected to Grow at a CAGR of 18.1%, from 2013 to 2018 - New Report by MicroMarket Monitor 2Health News:Agricultural Micro Irrigation System Market is Expected to Grow at a CAGR of 18.1%, from 2013 to 2018 - New Report by MicroMarket Monitor 3Health News:North America Fuel Additives Market is Expected to Reach $8,100 Million by 2017 - New Report by MicroMarket Monitor 2Health News:North America Fuel Additives Market is Expected to Reach $8,100 Million by 2017 - New Report by MicroMarket Monitor 3Health News:North America Fuel Additives Market is Expected to Reach $8,100 Million by 2017 - New Report by MicroMarket Monitor 4
... SILVER SPRING, Md., Aug. 21 The ... the Ethical Treatment of Animals (PETA) promoting vegetarianism at the expense ... an image of an overweight woman in a bikini, with the ... ." This ad is an unmistakable example of stigma and prejudice ...
... Ind., Aug. 21 Symmetry Medical Inc. (NYSE: SMA ... device industry and other medical markets, announced today that Brian S. ... Vice President and Chief Financial Officer, are scheduled to present at ... Hotel in Boston, MA on Wednesday, September 9, 2009 at 3:50 ...
... , , , ... Place More than 893 Minnesota Nursing Staff Jobs ... A new American Health Care Association (AHCA) analysis of the pending ... a recently-enacted Medicare regulation cutting Medicare-funded nursing home care, finds seniors in ...
... ... Help Plans Attract, Retain and Serve Health Insurance Consumers , ... Orlando, FL (Vocus) August 21, 2009 -- ... coverage. This is making individual consumers become more involved in the health insurance decision-making ...
... ( http://www.plosmedicine.org ) places in the public domain all ... and The New York Times intervention in the Prempro ... Medicine website at http://www.plosmedicine.org/static/ghostwriting.action , and are ... the court. The documents include internal correspondence, ...
... ASHEVILLE, N.C., Aug. 21 Type-A Mom Dieting Editor and ... the most success at dieting and weight loss are those who ... desired outcome. SMART is an acronym for the goal setting process ... and transforms them into a targeted strategy for measurable success. , ...
Cached Medicine News:Health News:The Obesity Society Calls Billboard Campaign Offensive and Off-Target 2Health News:Symmetry Medical to Present at Thomas Weisel Partners 2009 Healthcare Conference 2Health News:New Study of House Health Reform Bill: Minnesota Faces Over $654 Million in Medicare-Funded Nursing Home Cuts Over Ten Years 2Health News:Connextions Cited in Leading Industry Analyst Firm's 'Hype Cycle for Healthcare Payers' 2Health News:Connextions Cited in Leading Industry Analyst Firm's 'Hype Cycle for Healthcare Payers' 3Health News:Connextions Cited in Leading Industry Analyst Firm's 'Hype Cycle for Healthcare Payers' 4Health News:Ghostwriting documents now fully available on PLoS Medicine Web site 2
Clearview Chlamydia is a rapid, easy-to-use test for the detection of Chlamydia trachomatis from female endocervical swab specimens....
One inch disposable patch electrode uses a specially formulated adhesive solid gel. Reusable lead wire with snap connector provides economic benefits. Ideal for sleep studies where leg movement or EK...
One inch disposable patch electrode uses a specially formulated adhesive solid gel. Reusable lead wire with snap connector provides economic benefits. Ideal for sleep studies where leg movement or EK...
... Made with elastic fabric, these head cap ... need to begin testing. Each Electro-Cap System ... the International 10-20 System. When you place ... are using with your head cap system ...
Medicine Products: