CV THERAPEUTICS ANNOUNCES THAT ACS STUDY MISSES ENDPOINT
CV Therapeutics has announced that an analysis of unblinded data from the MERLIN TIMI-36 study shows there was no adverse trend in death or arrhythmias in patients on ranolazine. But the study did not meet the primary efficacy endpoint.
In accordance with its special protocol assessment agreement with the FDA, the company believes that the data could support expansion of the existing Ranexa (ranolazine extended-release tablets) indication to include first-line angina treatment.
MERLIN TIMI-36 is a multinational, 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 approximately 6,500 patients with non-ST-elevation acute coronary syndrome (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 MERLIN TIMI-36 have been studied in previous Phase III clinical trials.
Currently, 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, according to the company.