CVTX CV Therapeutics (MM)

CV Therapeutics Initiates Approval-Enabling Trial of Ranexa(TM) PALO ALTO, Calif., Aug. 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) announced today that it has initiated an approval-enabling study of Ranexa, which, if successful, could support approval of Ranexa for the treatment of chronic angina in a restricted patient population. The study is being conducted under the U.S. Food and Drug Administration's (FDA) special protocol assessment (SPA) process, as announced on June 2, 2004. "We are very excited to have initiated this approval-enabling study. In addition to the SPA agreement we have in place for this study, we also have a second SPA in place for the MERLIN trial, which could support potential approval of Ranexa as first-line therapy in chronic angina, and could also result in approval for treatment of acute coronary syndromes (ACS) and for long-term prevention of ACS," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc. 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 Design This approval-enabling study 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 will be 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 the study is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, this approval-enabling study 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