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Executive Summary

J&J BEPRIDIL CLINICAL TRIALS FOR ANGINA WILL CONTINUE, the company announced on Aug. 5. However, U.S. clinical trials of the calcium channel blocker for use as an anti-arrhythmic agent have been halted in patients with ischemic heart disease and/or premature ventricular contractions due to "additional deaths" appearing in the study data. J&J sublicenses bepridil from Carter-Wallace who licenses the drug from the Dutch firm Akzo. Carter-Wallace is discontinuing all its bepridil triaIs. In a recent letter to clinical investigators of bepridil, J&J announced that in a study of patients with ischemic heart disease and frequent premature ventricular contractions "some deaths have occurred in patients receiving bepridil." The firm said that "although the relationship between the drug and deaths is far from clear, in the interest of safety we are discontinuing this trial until data cam be further analyzed and evaluated." J&J said its bepridil studies in angina would continue, although they are being modified to exclude patients considered at risk. An NDA for bepridil has been pending at FDA since late 1983. The week before U.S. bepridil trials were halted, Akzo subsidiary Organon reportedly suspended clinicals in the U.K. due to adverse reactions. J&J said its decision to suspend U.S. clinicals was made independent of Organon's findings and decision to halt U.K. trials.

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