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Ranolazine Study Meets Primary Endpoint of Reducing Weekly Angina Frequency
Ranexa was well tolerated and there were no cases of syncope in the study.
Under the SPA agreement, these positive data from ERICA could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population. The company expects to prepare the final study report, integrate the data from ERICA into the safety and efficacy database of Ranexa trials and submit an amendment to the Ranexa new drug application (NDA) to the FDA by the end of the third quarter of 2005. Once the company submits the NDA amendment, a six month FDA PDUFA review could enable the potential approval and subsequent launch of Ranexa in a restricted patient population in the first half of 2006.
"We are very pleased with the success of Ranexa in ERICA in reducing angina in well managed patients. These results support an enhanced benefit risk profile for Ranexa and we look forward to potential approval under our SPA agreement once we have submitted the amendment to our NDA," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
The company plans to present the results from ERICA at a future scientific conference.
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 6.4 million people in the United States.
ERICA was a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in 565 patients with chronic angina who had more than three angina attacks per week 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 were 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. Long acting nitrates were allowed as background therapy at the start of the study, and were used by nearly half of patients.
The primary efficacy endpoint of ERICA was angina frequency. Other objectives of ERICA were to gather additional data on the safety and tolerability of Ranexa and to learn more about the effect of Ranexa on nitroglycerin consumption during angina attacks and quality of life.
Prior to entering the study, patients were required to have had at least two weeks of treatment with amlodipine 10 mg daily, with the discontinuation of other anti-anginal therapy for at least five days. Eligible patients must have had documented evidence of coronary artery disease or prior myocardial infarction, in addition to a diagnosis of chronic angina.
Source: CV Therapeutics, Inc.