CV Therapeutics,
Inc. (Nasdaq: CVTX) announced that the U.S. Food and Drug
Administration (FDA) has approved new language for the product labeling for
Ranexa(R) (ranolazine extended-release tablets) which describes the ability
of ranolazine to inhibit the late sodium current at therapeutic levels.
Published data on ranolazine's mechanism suggests that during ischemic
episodes excess sodium can flow into cardiac cells through sodium channels.
This excess sodium can trigger a subsequent overload of calcium that can
lead to problems with proper contraction and relaxation of the heart. Late
sodium current inhibition has been shown to improve mechanical and
electrical dysfunctions of cardiac cells under these circumstances.
"We believe it is important for physicians to have as much information
as possible on the mechanism of action for Ranexa and we are very pleased
that the FDA has worked with us to add this new language to the approved
product labeling," said Louis G. Lange, CV Therapeutics chairman and chief
executive officer.
Ranexa is currently 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. Complete product labeling is available at cvt.
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 product, Ranexa(R) (ranolazine
extended-release tablets), 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.
CV Therapeutics' clinical and preclinical drug development candidates
and programs include regadenoson, which is being developed for potential
use as a pharmacologic stress agent in myocardial perfusion imaging
studies, and CVT-6883, which is being developed as a potential treatment
for cardiopulmonary diseases. Regadenoson and CVT-6883 have not been
determined by any regulatory authorities to be safe or effective in humans
for any use.
Except for the historical information contained herein, the matters set
forth in this press release 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 operating losses and fluctuations in operating
results; capital requirements; regulatory review and approval of our
products; special protocol assessment agreement; the conduct and timing of
clinical trials; commercialization of products; market acceptance of
products; product labeling; concentrated customer base; reliance on
strategic partnerships and collaborations; uncertainties in drug
development; uncertainties regarding intellectual property; 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 June 30, 2007. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements.
CV Therapeutics, Inc.
cvt
View drug information on Ranexa.