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Executive Summary

FDA's Cardio-Renal Drugs Advisory Committee unanimously recommended approval for Medco's Adenocard (adenosine) in the treatment of paroxysmal supraventricular tachycardia at the panel's May 4 meeting. The committee found that data presented by Medco Research raised "no safety concerns" in using Adenocard in the termination of arrhythmias. However, committee reviewer Jeremy Ruskin, MD, Massachusetts General Hospital, remarked "if the drug were for prophylaxis, one could raise major concerns [about the data]." The committee also recommended that Adenocard therapy begin with a dose of 6 mg, increasing to a maximum dose of 12 mg in dosing intervals of two minutes. In one study that compared a 12 mg dose of Adenocard to a 7.5 mg dose of verapamil, Adenocard was found to have similar efficacy of about 95%. At 6 mg, Adenocard had only 60% efficacy compared to 80% for 5 mg of verapamil. Adenocard's time to conversion, however, was shorter than verapamil's -- 30 minutes versus 170 minutes. Medco has licensed manufacturing and marketing rights for Adenocard in the U.S. and Canada to Lyphomed and to Sanofi-France for the rest of the world. Medco has adenosine in development for at least seven other indications, including adjuvant to treatment of brain tumors (Phase II), prevention of myocardial reperfusion damage (Phase II), and as a substitute for exercise stress testing in diagnosis of coronary artery disease (Phase III).

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