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MEDCO RESEARCH RECONSIDERING FUTURE OF ORAL NAPA NDA

Executive Summary

MEDCO RESEARCH RECONSIDERING FUTURE OF ORAL NAPA NDA in light of the recent CAST study findings and FDA's request for more data, the company said August 14. Medco had reported in April 1988 that its NDA for NAPA (acecainide HCI) as a treatment for ventricular arrhythmia was on hold following an FDA request for additional information. On August 14, Medco noted that FDA was requesting "substantial additional data" to support the NDA for NAPA. "Compliance with the FDA's requirements . . . would be costly and time-consuming," the company predicted. Medco said it is now "in the process of determining its future course of action" on NAPA. The company is also taking into account what it perceives as "a cautious regulatory climate" stemming from the preliminary results of the Cardiac Arrhythmia Suppression Trial (CAST), sponsored by the National Institutes of Health. The study found rates of mortality among patients receiving two previously approved anti-arrhythmics products, Bristol-Myers' Enkaid (encainide) and Riker's Tambocor (flucainide), to be higher than those among patients receiving placebo. In April, labeling for both drugs was modified to restrict their use to life-threatening arrhythmias. Warner-Lambert holds worldwide marketing rights to NAPA based on a 1984 agreement with Medco. Warner-Lambert CEO Joseph Williams told analysts in January that NAPA "hopefully will be approved this year" ("The Pink Sheet" Jan. 30, p. 9). Warner-Lambert now says it is "considering its options." The clinical studies on NAPA were carried out by Medco after the firm acquired the drug from American Hospital Supply in November 1981. The NDA for an oral form of NAPA was filed in February 1986. Clinical studies for an injectable formulation have been completed; however, Medco has delayed filing an NDA for the injectable product pending approval of the oral form. Medco also noted that published data on animal research, carried out at the Vanderbilt University School of Medicine, has suggested that NAPA may be effective in allowing AICD (Automated Implantable Cardiac Defibrillator) devices, similar to pacemakers, to be implanted in high-risk patients who otherwise would not be able to receive the devices. Medco is seeking orphan status for NAPA for this use. In addition, Medco reported that it has received an orphan drug designation for MEDR 340 (adenosine) as a concomitant treatment with cytotoxic agents in brain tumors. Medco is studying the drug to see if it can increase blood flow to brain tumors. After a pilot study in approximately 15 patients in which the drug produced no serious side effects, the firm has reached an agreement with an undisclosed "well-known academic institution" to begin Phase I/II studies with adenosine in combination with the anticancer agent BCNU.
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