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STERLING's MILRIHONE I.V. CONGESTIVE HEART FAILURE NDA

Executive Summary

STERLING's MILRIHONE I.V. CONGESTIVE HEART FAILURE NDA is based on studies involving approximately 500 patients at 22 medical research institutions. The firm noted in a July 1 press release that the data was recently filed with FDA to complete its NDA submission for the intravenous form of milrinone. Sterling said the data shows that the drug has both direct inotropic effects, which "stimulate the failing heart to increase the amount of blood the heart pumps," and direct vasodilator properties, which "relax the blood vessels through which the heart pumps the blood and allows more blood to circulate more quickly." Two studies recently published in the literature describe the inotropic and vasodilator properties of milrinone I.V. The May issue of Circulation includes a study of 18 patients with congestive heart failure whose systemic, pulmonary, and coronary hemodynamics were measured before and after intravenous administration of milrinone. Investigators found that the drug produced a "45% increase in cardiac index . . . a 39% fall in the pulmonary capillary wedge pressure . . . and a 42% increase in left ventricular external work." They concluded that milrinone "can generally improve the condition of the patient with advanced congestive heart failure without worsening the balance between myocardial oxygen supply and demand, although some individual variability in response is evident." In the February issue of the Journal of Clinical Investigation there is a report of a study involving 11 patients who were given incremental intravenous doses of milrinone to determine the dose-response relationships for heart rate, systemic vascular resistance, and inotropic state. "Milrinone caused heart rate, stroke volume, and dP/dt to increase, and systemic vascular resistance to decrease in a concentration-related manner," the investigators stated. "These data in patients with severe heart failure indicate that in addition to a vasodilating effect, milrinone exerts a concentration-related positive inotropic action that contributes significantly to the drug's overall hemodynamic effects." Sterling submitted the initial portions of the milrinone I.V. NDA in March. The firm said the recent data, "along with other studies conducted abroad, will serve as the basis for other registration applications around the world." Sterling noted that an oral formulation of milrinone for extended outpatient management of congestive heart failure is currently in the advanced stages of Phase III testing.

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