CV Therapeutics reports study shows Ranexa cuts angina frequency

New York, Nov. 16 - CV Therapeutics Inc. said that a study of Ranexa (ranolazine) found that the drug met the goal of reducing weekly angina frequency compared to a placebo.

"Angina has a tremendous impact on many patients and families every year and there has not been a new medical approach to treating angina in the United States in more than a quarter century," said Peter Stone, co-director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital in Boston, in a news release.

"The clinical data suggest that, if approved, ranolazine could offer a new alternative for appropriate angina patients."

The results, from the Evaluation of Ranolazine in Chronic Angina study, were presented at the American Heart Association 2005 Scientific Sessions in Dallas on Wednesday.

CV Therapeutics included the results in an amendment to the Ranexa New Drug Application that was submitted to the U.S. Food and Drug Administration in July. The amendment was submitted as a complete response to an October 2003 approvable letter.

The Prescription Drug User Fee Act date for FDA action on the Ranexa amendment is Jan. 27, 2006.

The multi-national, double-blind, randomized, placebo-controlled, parallel group study included 565 patients with chronic angina suffering more than three attacks a week despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily).

Patients were given Ranexa (1000 mg twice daily) or a placebo and a daily dose of 10 mg of amlodipine during a six-week assessment period.

Ranexa significantly decreased mean angina episodes per week compared to the placebo and also significantly reduced mean nitroglycerin use per week without a change in heart rate or blood pressure.

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, CV Therapeutics said, adding that it affects 6.4 million people in the United States.

CV Therapeutics is a Palo Alto, Calif., biopharmaceutical company focused on applying molecular cardiology to small molecule drugs for the treatment of cardiovascular diseases.

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