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Executive Summary

SMITHKLINE BECKMAN FENOLDOPAM CLINICALS IN CHRONIC HYPERTENSION HALTED "recently" due to the lack of efficacy with the oral form of the drug, SmithKline said. The firm added that it is "aggressively pursuing worldwide development of oral fenoldopam in congestive heart failure and renal failure." The oral fenoldopam hypertension trials are being terminated in Phase III, while studies of the oral dopamine agonist/renal vasodilator in congestive heart failure and renal failure are progressing through Phase II. SmithKline added that it is continuing its "major development program" for the I.V. form of fenoldopam in the treatment of acute hypertensive emergencies and in congestive heart failure. The firm said that the drug has shown good efficacy in acute indications but not for chronic disease. Outside of Ridaura and the firm's program to expand Tagamet labeling, oral fenoldopam was the furthest along of SmithKline's research agents in the pipeline. A second dopamine agonist, ibopamine, is projected to move into Phase III trials this year. SmithKline continues to gear up for approval of Ridaura, the oral gold compound expected sometime this year. The company's first internal sales promotion for Ridaura reportedly took place the last week of April in Philadelphia. The Ridaura NDA has been reviewed twice by FDA's Arthritis Drugs Advisory Cmte.: in January 1982 the panel recommended approval of the drug for remission of rheumatoid arthritis; and more recently, in October 1984, the panel reviewed additional clinical data and discussed labeling of the compound.

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