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| |  TARKA, Combination ACE inhibitor/CCB Receives FDA Clearance MT. OLIVE, N.J.—Nov. 8, 1996 -- TARKA(R), a combination of the ACE inhibitor trandolapril and the calcium channel blocker verapamil HCl ER, has received U.S. Food and Drug Administration clearance for marketing, Knoll Pharmaceutical Company announced today. TARKA, which is indicated for the treatment of hypertension as second line therapy, is designed to help those patients who require more than single agent therapy with the calcium channel blocker (CCB) or the ACE inhibitor components to adequately control their blood pressure. With TARKA, trandolapril and verapamil HCl ER work together in a complementary manner to lower total peripheral resistance, which affects the heart's work output and is considered the most common contributor to hypertension from non-specific causes. "Although TARKA is not indicated for first line therapy, it is an extremely effective option for patients when treatment with either single agent has not yielded adequate results," said Ed Kirsten, Ph.D., Director of Cardiovascular Research at Knoll Pharmaceutical Company. "Physicians no longer need to push the dose of single agent therapy to levels where side effects become intolerable." TARKA offers once-a-day dosing, complementary mechanisms of action which decrease peripheral resistance and lower blood pressure. The product is well-tolerated and also offers therapy that is low cost and convenient. TARKA has no significant effect on key metabolic parameters. It is for these reasons that TARKA is truly a "complementary combination" of the ACE inhibitor and calcium channel blocker for the treatment of hypertension. In controlled clinical trials, blood pressure reductions were significantly greater for TARKA than for either of the components used alone at the 4/240mg dose. Additionally, TARKA was very well tolerated, with a favorable side effect profile. The most common side effects were cough (4.6%), first degree AV block (3.9%), constipation (3.3%) and dizziness (3.1%). A variety of studies in the United States and Europe found that the use of trandolapril and verapamil HCl ER in fixed combination for the treatment of hypertension does not increase the incidence of side effects over monotherapy with each component and improves control of hypertension. Additionally, in a randomized, open label, multi-center study of 98 patients, combination therapy was equally effective in lowering blood pressure in black and non-black patients with severe hypertension. Dr. Kirsten added that there is compelling evidence that TARKA may reduce blood pressure without negatively impacting metabolism, making it a potentially valuable therapy for hypertensive patients with accompanying diabetes. Beginning in January, TARKA Tablets will be available nationwide in four strengths to offer physicians greater dosing flexibility. TARKA is contraindicated in patients who are hypersensitive to any ACE inhibitor or verapamil HCl and in patients with a history of angioedema. In addition, use during the second and third trimester of pregnancy is contraindicated. Full prescribing information is available upon request. Knoll Pharmaceutical Company, headquartered in Mt. Olive, New Jersey, is the U.S. pharmaceutical unit of BASF Corporation and part of BASF Pharma, the global pharmaceutical division of BASF AG. Knoll is dedicated to the development and marketing of prescription drugs for cardiovascular disease, pain management, endocrine, immune and central nervous system disorders.
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