Executive Summary

STERLING's INOCOR (AMRINONE) I.V. IS "APPROVABLE" the company announced in a May 23 press release. The drug will be marketed to U.S. physicians and hospitals by Sterling's Winthrop-Breon Labs pending FDA approval of labeling and packaging information. Sterling said that Inocor I.V. will be used in hospitals among patients with severe congestive heart failure unresponsive to other therapies. The release describes amrinone as an "inotropic agent which improves directly the pumping force of the heart and serves simultaneously as a mild dilator of the blood vessels." The approval of the I.V. form of amrinone follows in the wake of Sterling's decision in January to halt clinical studies on the oral form of the drug because of a high incidence of gastro-intestinal side effects (The Pink Sheet" Jan. 23, T&G-2). In October 1982, FDA's Cardio-Renal Drugs Advisory Cmte. declined to recommend approval of oral amrinone until Sterling completed an additional long-term clinical study. However, after preliminary review of the study showed that the high incidence of gastrointestinal side effects was causing a drop out rate that would make it difficult to establish statistical significance of efficacy, Sterling made the decision to halt work on the oral drug. The company has not withdrawn its pending NDA from FDA on that form, however. Along with the announcement in January of its decision to halt the clinical study with oral amrinone, Sterling said that it intended to "accelerate both oral and intravenous studies on milrinone," an analogue of amrinone also for the treatment of congestive heart failure. Sterling noted that preliminary clinical studies have show that milrinone "is 10 to 30 times more potent than amrionone, Sterling's first inotropic discovery, and has been remarkably free of side effects." The company said that milrinone "has entered expanded clinical trials for both oral and intravenous dosage forms. Results with both forms appear encouraging."