FDAnews
www.fdanews.com/articles/75343-cv-therapeutics-announces-results-of-regadenosen-trial

CV THERAPEUTICS ANNOUNCES RESULTS OF REGADENOSEN TRIAL

August 12, 2005

CV Therapeutics has announced that a drug it hopes to market for heart-imaging studies met its primary endpoint in a Phase III trial. The drug, regadenoson, is being developed as an alternative to another drug, Adenoscan. The 784-patient trial showed that patients tolerated regadenoson well, and that it compared well to Adenoscan.

Regadenoson, which has not yet been approved by regulators, is meant to increase blood flow and dilate coronary arteries that supply the heart so that a scan will show blockages or restrictions. Most patients exercise on a treadmill to boost blood flow, but drugs have to be used for about 40 percent of them who aren't able to walk or run on the treadmill because of arthritis or other problems.

A second Phase III trial of the drug is underway, and if it is also successful, the two companies will apply for marketing approval from the FDA.