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

    NASDAQ: CRME   TSX: COM

VANCOUVER and DEERFIELD, IL, Aug. 10 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") announced today that Astellas will undertake a single confirmatory additional Phase 3 clinical trial of KYNAPID(TM) (vernakalant hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus rhythm. The trial, to be called ACT 5, is expected to begin enrolling patients by the end of 2009, with completion expected in the first half of 2011.

The decision to conduct another trial was reached following extended discussions with the FDA to define the best regulatory path forward for KYNAPID. Under the Special Protocol Assessment (SPA) process, the FDA has agreed that the design and planned analysis of the study adequately address objectives in support of the KYNAPID New Drug Application (NDA). The prospectively-defined trial will enroll recent-onset atrial fibrillation patients without a history of heart failure. Cardiome and Astellas believe that this study, coupled with the overall clinical development program, should in principle meet the FDA standards for approval.

"In addition to receiving a positive recommendation for approval from the FDA Cardiovascular and Renal Drugs Advisory Committee, KYNAPID has demonstrated consistent results across all of the four completed Phase 3 clinical trials," said William E. Fitzsimmons, PharmD, Senior Vice President, Development at Astellas. "We are confident that the ACT 5 trial will confirm these prior results and further demonstrate the therapeutic value of this exciting drug candidate."

"We support the decision to conduct the ACT 5 trial, and we will assist our partner Astellas in every way to expedite the launch and successful completion of this study," said Doug Janzen, President and Chief Executive Officer of Cardiome. "We estimate that Cardiome's alloca
'/>"/>

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:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and David ... Show to bestow a Juvent Sports Achievement award upon ... McKitrick. The award commemorated and congratulated McKitrick for her ... won her first amateur tournament in 1979 and most ...
(Date:1/22/2015)... 2015 Autocarinsurancebest.com has released a new blog ... auto insurance policy . , Auto insurance quotes help ... is no longer necessary to call an agent or visit ... online on a single website: http://autocarinsurancebest.com/ . , Every ...
(Date:1/22/2015)... Plainsboro, NJ (PRWEB) January 22, 2015 ... advocate and keynote speaker at the upcoming 32nd ... by ACCME-accredited Physicians’ Education Resource®, LLC (PER®) , ... breast would have gone undetected if she had not ...
(Date:1/22/2015)... (PRWEB) January 23, 2015 Recently, Weddingshe.com has ... catalog, and has announced its highest annual revenues in the ... on its popular glamorous wedding dresses. , According to the ... important wedding dress promotions for them in 2015. This point ...
(Date:1/22/2015)... WASHINGTON, DC (PRWEB) January 22, 2015 ... conditions in vulnerable communities and cause financial distress to ... report by analysts at Howard University’s Center on Race ... of dollars in economic activity, payday loans at the ...
Breaking Medicine News(10 mins):Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2
... Derek Kirchen, 67, who had suffered pneumonia eight times and ... their wits end, making sense of the symptoms and providing ... clues, doctors had cautioned Kirchen that the symptoms may be ... surgery, Dr Syed Tariq, a respiratory physician, stumbled upon a ...
... using dummy due to different developmental, hygienic or aesthetic reasons. ... dummies are bad for babies and parents should be in ... 20 studies conducted over the world since from past decade ... dummies are prone to reject or breastfeed for a shorter ...
... We might feel that we have forgotten certain things in ... that whatever we have forgotten does still stay in our ... and Roberto Cabeza of Duke University, conducted a study in ... we think it, does. According to the online edition of ...
... May that one adult and two children have been diagnosed with ... statement confirming that there have been three linked cases of E.coli ... these cases have a link with J&H Cairns, a butcher in ... no conclusive evidence yet that J&H Cairns is the source of ...
... UN sponsored conference on aviation flu has called ... facility involving all relevant institutions across the globe, ... bird watchers and wildlife conservation societies to check ... ,Scientists attending the conference convened by the UN ...
... led young people to name heroin as a loser ... which includes providing alternative narcotics and needle exchange programs, ... to consider the substance ‘loser drug,’ a Lancet study ... in Zurich said: The policy provides an alternative narcotics ...
Cached Medicine News:Health News:Diagnosis On a Fourth Patient Confirmed To Be E.Coli 2
(Date:1/23/2015)... TOWN, South Africa , Jan. 23, 2015   ... distributor of personal protective equipment for all forms of ... the flagship Leatt-Brace® neck brace, announced today that the ... racing federation, now requires all riders to wear a ...
(Date:1/23/2015)... Gem Pharmaceuticals announced today that the initial soft ... Company,s Phase 2 clinical trial.  This open-label study will ... GPX-150 (an investigational medication), in approximately 30 adults as ... Logo - http://photos.prnewswire.com/prnh/20150123/170966LOGO GPX-150 ...
(Date:1/22/2015)... , Jan. 22, 2015  ViewRay™, a privately held ... into an exclusive distributor agreement with ITOCHU Corporation (Tokyo ... therapy system for the treatment of cancer in ... system, is the world,s first and only MRI-guided radiation ...
Breaking Medicine Technology:Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2ITOCHU Named the Exclusive Distributor for ViewRay's MRI-Guided Radiation Therapy System in Japan 2
... March 29, 2011 Sigma-Aldrich Corporation (Nasdaq: SIAL ... new website, www.sigma-aldrich.com . The new site has been ... to help researchers more easily find the information, tools, products ... Company plans to continue to roll out innovative upgrades to ...
... A woman,s face tells her story but sometimes showing a ... and more, the quest continues for new ways to keep ... new Face Forward survey commissioned by Ulthera ® (the ... the FDA with a non-invasive lift indication), 83 percent of ...
Cached Medicine Technology:Sigma-Aldrich Unveils Dynamic New Web Presence 2Sigma-Aldrich Unveils Dynamic New Web Presence 3What Would Women Give Up for a More Youthful Face? 2What Would Women Give Up for a More Youthful Face? 3
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: