Navigation Links
Additional Clinical Trial to be Conducted for KYNAPID Under FDA Special Protocol Agreement
Date:8/10/2009

he replay.

About KYNAPID

KYNAPID (vernakalant hydrochloride) Injection, or vernakalant (iv), is an investigational new drug for the rapid conversion of acute atrial fibrillation to sinus rhythm. Its mechanism of action involves the selective blockade of multiple ion channels in the heart that are known to be active during episodes of atrial fibrillation.

In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize KYNAPID in North America, with Astellas responsible for 75% of development costs. Astellas and Cardiome conducted four successful Phase 3 clinical trials which demonstrated the potential for KYNAPID as a conversion agent. In December 2004 and September 2005, we announced positive top-line results for the first and second pivotal Phase 3 atrial fibrillation trials, or ACT 1 and ACT 3, respectively. In addition, positive top-line results from ACT 2, evaluating KYNAPID for the treatment of atrial fibrillation following cardiac surgery, were announced in June 2007. Astellas also conducted an open-label safety study, or ACT 4, in order to gather additional safety data.

The NDA for KYNAPID was submitted in December 2006. In December 2007, the FDA Cardiovascular and Renal Drugs Advisory Committee recommended to the FDA that KYNAPID be approved for rapid conversion of acute atrial fibrillation to sinus rhythm. In August 2008, Astellas received an Approvable letter from the FDA.

About Cardiome

Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. Cardiome is traded on the NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.

About Astellas


'/>"/>
SOURCE Cardiome Pharma Corp.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine news :

1. aTyr Pharma Raises an Additional $12 Million
2. Texas Kidney Community: CMS Authorization to Survey 22 New Dialysis Centers Excellent First Step Toward Opening Additional Pending Facilities, Creating More Local Jobs
3. SETO Holdings, Inc. Enters Into Two Additional Leases for Two New Hearing Centers in Maryland and Virginia
4. Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol
5. For Treatment of Type 2 Diabetes, 89 Percent of Surveyed Endocrinologists Identify a Need for Additional GLP-1 Analogues and 71 Percent Say the Same About DPP-IV Inhibitors
6. Specialty Hospitals of Washington Adds Additional Skilled Nursing Facility Beds at United Medical Center in South East DC
7. King Provides Additional Information on the REMOXY(R) NDA Resubmission Plan
8. Visit to the doctor: The supply of additional private services is increasing
9. Business, Health Care Leaders Call on Texas Employers to Cover Smoking Cessation Benefits for an Additional 100,000 People by 2010
10. Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)
11. New Jersey University Hospital to Pay Additional $2 Million to Resolve Fraud Claims That Facility Double Billed Medicaid
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... August 22, 2014 Dealing with a drug ... when the addict is a child. Adolescent substance abuse has ... a long time. But a new helpline is now providing ... professional youth rehab for something like a teen drug ... designed to help make a positive impact in the community. ...
(Date:8/22/2014)... August 22, 2014 According to ... System and Adaptive Cruise Control (ACC) System Market ... Forecasts 2014 - 2019", published by MarketsandMarkets, classifies ... Market in terms of volume and value. The ... years as well as covers review of the ...
(Date:8/21/2014)... August 22, 2014 The natural loss of ... lines, wrinkles and sagging of skin. Using products to ... age 40, the body has lost about 15% of it ... 45%," says Kathy Heshelow, founder of Sublime Beauty®. "Collagen ... it - well, we know what happens." , Collagen in ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 Local agencies ... have larger discounts for specific protection plans, according to ... helping consumers to quote life insurance from local agencies ... The local agents that appear inside of the national ... fast method of price reviews this year. Adults who ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 AVEC ... to announce the addition of Kerry Gillespie as ... of healthcare management experience, Gillespie brings an extremely ... multiple executive management positions with prominent industry leading ... served as President of Triad Isotopes, Inc. a ...
Breaking Medicine News(10 mins):Health News:Cincinnati’s New Troubled Teen Helpline is Making a Difference in the Community 2Health News:Automotive Blind Spot Detection System Market Worth $2.8 Billion and Automotive Adaptive Cruise Control System Market Worth $6.1 Billion by 2019 – New Report 2Health News:Automotive Blind Spot Detection System Market Worth $2.8 Billion and Automotive Adaptive Cruise Control System Market Worth $6.1 Billion by 2019 – New Report 3Health News:Automotive Blind Spot Detection System Market Worth $2.8 Billion and Automotive Adaptive Cruise Control System Market Worth $6.1 Billion by 2019 – New Report 4Health News:4 Skincare Products That Boost and Nurture Collagen on Sale at Sublime Beauty® 2Health News:4 Skincare Products That Boost and Nurture Collagen on Sale at Sublime Beauty® 3Health News:Life Insurance from Local Agents Now Priced Nationally Through Complimentary Tool Online 2Health News:Kerry Gillespie Appointed as Chief Executive Officer of AVEC Health Solutions 2
... campuses of the University of California has found that flash-heating ... virus. ,The researchers hope that this technique - ... pan of water over a flame or single burner - ... nations will soon be able to more safely feed their ...
... rigorous U.S. trial comparing two traditional operations for stress ... urologists and urogynecologists supported by the National Institutes of ... more women achieve dryness than the Burch technique. ... a meticulous, relatively long-term comparison of these common surgeries ...
... given people another reason to quit smoking, by finding that ... depression in comparison to those who never smoke. ,The ... an elevated risk of depressive symptoms in short run, this ... long run. ,In other words, both completely ...
... Well, it doesnt have to be that way ... say that they have successfully managed to reduce ... containing vitamin A. ,Not only did the ... 23 people revealed it boosted levels of important skin ...
... a condition that most people prefer not to talk about, ... this embarrassing problem. It's called overactive bladder (OAB) and ... sometimes causing urine leakage. ,Now, to reduce the ... using nerve stimulation in the ankle to better help control ...
... chronic gum disease periodontitis, may have an increased risk of ... ,Periodontitis is an oral infection thought to be caused by ... well. ,The study was conducted by a team ... of New York at Buffalo and the Roswell Park Cancer ...
Cached Medicine News:Health News:Flash-heating Inactivates HIV in Breast Milk: Study 2Health News:Flash-heating Inactivates HIV in Breast Milk: Study 3Health News:Sling Surgery Better Than Burch for Treating Stress Incontinence in Women 2Health News:Sling Surgery Better Than Burch for Treating Stress Incontinence in Women 3Health News:Regular Smokers are at the Risk of Developing Depression 2Health News:Wrinkles can Be Really Ironed Out, Thanks to Vitamin A 2Health News:Stimulating the Ankle Can Help Patients With Overactive Bladder 2Health News:Men With Chronic Gum Disease at Higher Risk of Tongue Cancer 2
(Date:8/21/2014)...  Vermillion, Inc. (NASDAQ: VRML ), a ... health, has appointed Holly B. Bauzon as ... Ms. Bauzon has a proven track record in both ... services companies. She has more than 20 years of ... held the position of Director, Lab Services Sales and ...
(Date:8/21/2014)... Aug. 21, 2014  eRelevance Corporation ( www.erelevancecorp.com ... today that it has completed integration with Nextech, ... Plastic Surgery and Dermatology practices. "Integration ... to healthcare practices using Nextech," stated Bob ... "Using information from the EMR we are able ...
(Date:8/21/2014)... YORK , Aug. 21, 2014  Publicis Groupe ... Shannon Hartley , Managing Partner and Healthcare Industry Group ... PharmaVoice 100, which recognizes the most inspiring people in ... are leaders in research and development, marketing, technology, creativity, ... agency in 2006 as a partner in its leading ...
Breaking Medicine Technology:Vermillion Appoints Holly B. Bauzon as VP of Sales and Managed Markets 2eRelevance Corporation Integrates with Nextech Electronic Medical Records 2Shannon Hartley Shines in PharmaVOICE 100 2
... take the words "mobile operating table" literally! The ... important functions of a general purpose operating table ... For table operations, a cable connected hand control, ... available. Plus, there is a control panel at ...
... carbon fiber c-arm table allows 50 ... brachytherapy, gynecology, gastroenterology, cardiovascular, orthopedic, ENT, ... design allows easy access for all ... 16-inch elevating travel, 16-inch longitudinal travel, ...
... for procedures where stability, access, and ... A cantilevered low attenuation carbon fiber ... The radiolucent area is free of ... and unobstructed C-Arm positioning. Functional design ...
... Lyphochek Elevated Immunosuppressant Control is a bilevel ... blood. This unique product is ideal for ... high Cyclosporine levels, such as C2 monitoring, ... at two hours post-dose., ,Lyphochek Elevated Immunosuppressant ...
Medicine Products: