JACC Publishes ERICA Trial Results Showing Ranexa(R) Reduces Angina Frequency and Nitroglycerin Consumption
June 19 2006 - 8:00AM
PR Newswire (US)
PALO ALTO, Calif., June 19 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the Journal
of the American College of Cardiology (JACC) has published data
from the Efficacy of Ranolazine In Chronic Angina (ERICA) trial. In
the ERICA trial, Ranexa(R) (ranolazine extended-release tablets)
significantly reduced angina frequency (p=0.028) and nitoglycerin
consumption (p=0.014) in angina patients compared to placebo.
Forty-five percent of patients in the study were on concomitant
long acting nitrates. Ranexa was well tolerated and there were no
observed differences in the frequency of serious adverse events
between Ranexa and placebo. "Angina places a tremendous burden on
patients, their families and the healthcare system, and the results
of the ERICA study highlight how ranolazine could benefit a portion
of this population," said Peter Stone, M.D., lead author of the
publication and co-director, Samuel A. Levine Cardiac Unit, Brigham
and Women's Hospital in Boston. "Ranolazine represents the first
new pharmaceutical approach in decades for physicians to consider
in treating appropriate angina patients." Ranexa is approved in the
United States as a second-line treatment for chronic angina and has
antianginal and anti-ischemic effects that do not depend upon
reductions in heart rate or blood pressure. Ranexa should be used
in combination with amlodipine, beta-blockers or nitrates.
According to the approved labeling, because Ranexa prolongs the QT
interval, it should be reserved for patients who have not achieved
an adequate response with other antianginal drugs. The effect on
angina rate or exercise tolerance appeared to be smaller in women
than men. The ERICA study was published online by JACC and is
expected to be included in a future print edition of JACC. An
editorial from John Cairns, M.D., professor of cardiology at the
University of British Columbia in Vancouver, accompanies the
publication. Complete prescribing information for Ranexa, including
detailed safety and dosage information are available at
http://www.ranexa.com/. About CV Therapeutics CV Therapeutics,
Inc., headquartered in Palo Alto, California, is a
biopharmaceutical company focused on applying molecular cardiology
to the discovery, development and commercialization of novel, small
molecule drugs for the treatment of cardiovascular diseases. CV
Therapeutics' approved products include Ranexa(R) (ranolazine
extended- release tablets) and ACEON(R) (perindopril erbumine)
Tablets. Ranexa is indicated for the treatment of chronic angina in
patients who have not achieved an adequate response with other
antianginal drugs, and should be used in combination with
amlodipine, beta-blockers or nitrates. In addition, CV Therapeutics
co-promotes ACEON(R), an ACE inhibitor, for reduction of the risk
of cardiovascular mortality or nonfatal myocardial infarction in
patients with stable coronary artery disease and treatment of
essential hypertension. CV Therapeutics also has other clinical and
preclinical drug development candidates and programs, including
regadenoson, which is being developed for potential use as a
pharmacologic stress agent in myocardial perfusion imaging studies.
Regadenoson has not been approved for marketing by any regulatory
authorities. Except for the historical information contained
herein, the matters set forth in this press release, including
statements as to development, conduct of clinical studies, study
results, regulatory review and approval, and commercialization of
products, are forward-looking statements within the meaning of the
"safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are subject to
risks and uncertainties that may cause actual results to differ
materially, including, early stage of development; regulatory
review and approval of our products; the conduct and timing of
clinical trials; commercialization of products; market acceptance
of products; product labeling; and other risks detailed from time
to time in CV Therapeutics' SEC reports, including its Quarterly
Report on Form 10-Q for the quarter ended March 31, 2006. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: Christopher Chai, Vice President, Treasury and Investor
Relations, +1-650-384-8560, or John Bluth, Senior Director,
Corporate Communications, +1-650-384-8850, both of CV Therapeutics,
Inc. Web site: http://www.cvt.com/
Copyright
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Jun 2024 to Jul 2024
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Jul 2023 to Jul 2024