"The results of the MERLIN TIMI-36 study confirm that ranolazine is a safe and effective anti-ischemic drug that also has favorable effects on arrhythmia and HbA1c," Morrow said. "The reduction in HbA1c observed with ranolazine in the MERLIN TIMI-36 study is especially striking because the effects were observed on top of multiple other anti-diabetic drugs used as part of standard therapy."
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. In September 2007, the Company submitted a supplemental new drug application to the FDA seeking a new indication for first line angina and a significant reduction in cautionary language.
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 treatment. The
doses of Ranexa extended-release tablets used in MERL
|SOURCE CV Therapeutics, Inc.|
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