CVTX CV Therapeutics (MM)

CV Therapeutics and FDA Agree to Special Protocol Assessment for Approval-Enabling Study of Ranexa(TM) - Management to Host Conference Call Today at 5:30 p.m. EDT/2:30 p.m. PDT - PALO ALTO, Calif., June 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) announced today that the company and the U.S. Food and Drug Administration (FDA) have reached written agreement on a protocol for a clinical trial of Ranexa(TM) (ranolazine) which, if successful, would 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. "We have been working closely with the FDA to reach agreement on a study that, if successful, would support the approval of Ranexa in the United States, and we are pleased to have reached agreement under the SPA process for a single approval-enabling study. We anticipate being able to begin enrollment in this study in the third quarter. We also plan to initiate at least one additional clinical trial later this year to support approval of Ranexa in a broader patient population," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. 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 The study will be 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 will be 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