CVTX CV Therapeutics (MM)

CV Therapeutics Completes Enrollment of ERICA, an Approval-Enabling Study of Ranexa(TM) (ranolazine) PALO ALTO, Calif., Nov. 16 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) announced today that investigators have completed patient enrollment of the potentially approval-enabling Evaluation of Ranolazine In Chronic Angina (ERICA) study. "We are pleased that the pace of enrollment has exceeded our expectations and we now expect data solidly in the second quarter of 2005," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. CV Therapeutics and the U.S. Food and Drug Administration (FDA) have a written 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. Study Details 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 labeled 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 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo (p