These data represent the first clinical report of the effect of ranolazine to reduce the incidence of cardiac arrhythmias and support the findings of many prior preclinical studies which have suggested that ranolazine has potential anti-arrhythmic properties due to its action as an inhibitor of the late sodium current.
In accordance with a special protocol assessment agreement between the U.S. Food and Drug Administration (FDA) and CV Therapeutics, the Company believes that data from the MERLIN TIMI-36 study could support expansion of the existing Ranexa indication to first line angina, and plans to submit a supplemental new drug application to the FDA in fall 2007. CV Therapeutics plans to ask the FDA to modify the existing product labeling for Ranexa by reducing cautionary language and expanding the indication to include first- line angina.
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.
MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) was a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in 6,560 patients (3,279 received ranolazine, 3,281 received placebo) with non-ST elevation ACS treated with standard therapy.
Within 48 hours of the onset of angina due to ACS, eligible
hospitalized patients were enrolled in the study and randomized to receive
intravenous Ranexa or placebo, followed by long-term outpatient treatment
with Ranexa extended-release tablets or placebo. All patients also received
standard therapy during both hospital-based and outpatient treatm
|SOURCE CV Therapeutics, Inc.|
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