SMITHKLINE BEECHAM ORAL FENOLDOPAM FOR CONGESTIVE HEART FAILURE

Executive Summary

SMITHKLINE BEECHAM ORAL FENOLDOPAM FOR CONGESTIVE HEART FAILURE is dropped from R&D program due to lack of efficacy. "Recent clinical trials of the oral form of fenoldopam for congestive heart failure have indicated that it does not provide significant clinical benefit relative to existing therapies," the firm said in a September 27 release. The negative results were obtained from three pivotal Phase III studies, which were conducted in the U.S. and overseas and included over 1,000 patients. SmithKline Beecham emphasized that its decision to discontinue development is based solely on efficacy results, and "not based on any concern about the safety of the drug." The firm is continuing to develop oral fenoldopam for chronic renal failure, currently in Phase III studies. An I.V. formulation of the inotropic agent is also under development for a number of conditions. An NDA was submitted in December 1988 for severe hypertension and the intravenous agent is in Phase III for cardiac failure and Phase II/III for acute renal failure. Poor study results with oral fenoldopam follow on the heels of disappointing results for another congestive heart failure drug, Boots' Manoplax (see related item below). Preliminary results from Phase III studies in the U.S. and U.K. did not show significant improvement for patients treated with the drug. Boots says it may discontinue development of the drug in certain countries or completely, depending on final results from the Phase III studies.