Pharmaceutical Business review

CV heart therapy disappoints in trial

Despite its failure to provide effectiveness for acute coronary syndrome (ACS), CV said there was no adverse trend in death or arrhythmias in patients on Ranexa.

The company also believes that the data could support the extension of the existing indication to first-line angina for Ranexa.

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.

The trial was designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients 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.