CV Therapeutics, Inc. has announced that Ranexa (ranolazine) met the primary endpoint of reducing weekly angina frequency compared to placebo in the Evaluation of Ranolazine In Chronic Angina (ERICA) study. ERICA was conducted under the US FDA's special protocol assessment (SPA) process, following an approvable letter issued in October 2003. 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, the release said.

"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, 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 6.4 million people in the United States.

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.