CV Therapeutics, Inc. announced that investigators have completed patient enrolment of the potentially approval-enabling Evaluation of Ranolazine In Chronic Angina (ERICA) study.
CV Therapeutics and the US FDA have written an agreement on the protocol for ERICA, which, if successful, could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population. This agreement was reached under the FDA's special protocol assessment (SPA) process.
If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.
"We are pleased that the pace of enrolment has exceeded our expectations and we now expect data solidly in the second quarter of 2005," said Louis G. Lange, chairman and chief executive officer of CV Therapeutics.
ERICA is a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labelled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients are being randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six-week assessment period.
The primary efficacy endpoint of ERICA is angina frequency. Based on the reduction in angina frequency observed in the phase III CARISA study, ERICA is calculated to be 95 per cent powered to detect a statistically significant reduction in angina frequency due to Ranexa.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA). In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise, the company said in a release.
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.