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Executive Summary

SQUIBB HAS ACE-IN-THE-HOLE FOR MS&D's VASOTEC: CAPOZIDE LAUNCH set to begin simultaneously with Merck's launch of Vasotec. FDA approved the fixed combination of the angiotensin converting enzyme inhibitor captopril and the diuretic hydrochlorothiazide in the fall of 1984. Squibb has withheld introduction of the product until Jan. 16, 1986. The NDA for Capozide was filed in April 1982. The delayed launch gives Squibb a new product to play against Merck's Vasotec (enalapril), which will be the second ACE inhibitor to reach the market after clearing FDA on Dec. 24. Advertisements for Capozide have already appeared in January issues of publications such as the Journal of the American Medical Assn. and the New England Journal of Medicine. An NDA for Merck's enalapril/hydrochlorothiazide combination, Vasoretic, is currently pending at FDA. In press material on the Capozide introduction, Squibb emphasizes the additive effects of the two drugs in the combo. Quoting Capozide investigator Myron Weinberger, MD, Indiana University, the release states: "Capozide's most important contribution is that it lowers blood pressure more effectively than either drug given individually and is well accepted by the patient. It works in an extremely logical fashion to control hypertension in most patients." Squibb adds that the combination lessens "some of the metabolic side effects caused by diuretics. With the new medication, patients requiring the control of two antihypertensive agents usually do not have to take potassium supplements, as they frequently do when diuretics are taken alone. The combination enables blood pressure control often with lower doses than required with single-agent therapy." Capozide labeling states that the drug is "indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive." The labeling also includes the bold-faced statement: "This fixed combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient's needs, it may be more convenient than the separate components." Labeling adds that "Capozide may be used for patients with normal renal function, in whom the risk [of neutropenia/agranulocytosis] is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, Capozide should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations." The insert warns that "thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function." Capozide and captopril labeling indications were expanded for across-the-board hypertension therapy in August 1985. Prior to that, labeling restricted use of both drugs to patients with severe hypertension. Squibb said the company delayed marketing Capozide until Capoten was relaunched to physicians after the expanded label claim was approved by FDA. Bottles of 100 captopril/hydrochlorothiazide tablets are priced to whslrs. at: $30.20 for 25/15 mg; $30.87 for 25/25 mg; $49.68 for 50/15 mg; and $50.35 for 50/25 mg.

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