Verelan

Business Editors & Health/Medical Writers

MILWAUKEE--(BUSINESS WIRE)--Sept. 3, 2002

A recent study has confirmed the efficacy and safety of Verelan(R) PM (verapamil HCl) for the control of morning blood pressure following bedtime dosing in a wide range of hypertensive patients, lowering both morning systolic and diastolic blood pressure in all ethnic groups.

The study provides a boost for patients seeking an easy-to-use, effective means of managing their hypertension.

Verelan PM, a chronotherapeutic dosage form of the calcium channel blocker verapamil, is intended to complement the body's natural circadian rhythms for the management of essential hypertension. The study (Controlling Hypertension in the moRning with a ChrONO Med or C.H.R.O.N.O.) results were presented at the 17th Annual Scientific Meeting of the American Society of Hypertension (ASH).

"Only 27% of Americans with hypertension have their blood pressure adequately controlled despite the existence of at least 115 antihypertensive medications. Improving blood pressure management, therefore, has become a key clinical priority," said L. Michael Prisant MD, Hypertension and Clinical Pharmacology, Medical College of Georgia. "The C.H.R.O.N.O trial results underscore the desirability of Verelan PM titration, since higher doses are associated with greater reductions in blood pressure. In the study, 20% of patients were African American, 4% were Hispanic American, and 4% were Asian American. This confirms the efficacy and safety of Verelan PM in a wide variety of patients."

Verelan PM Effective for African, Hispanic and Asian Americans

While all groups had positive results in the study, Dr. Prisant was extremely pleased with the results for specific ethnic groups for whom hypertension may be more prevalent (African and Hispanic Americans) or unrecognized (Asian and Hispanic Americans). The prevalence of hypertension in African Americans is among the highest in the world, diseases of the heart and stroke rank as the No. 1 killer of Latinos, and compared to most Americans, Asian Americans are less likely to be aware of hypertension or to be undergoing treatment.

In the Verelan PM study, there was a reduction of:

Dr. Prisant and the investigators evaluated Verelan PM in 2,556 patients with stage I or II essential hypertension who had not been treated at all or had been previously treated with one antihypertensive agent. Patients were started on 200 mg per day at bedtime and were then titrated at four-week intervals until they reached a target blood pressure of 140/90 mmHg, or reached a maximum dosage of 400 mg per day.

With Verelan PM, 85.3% of all participants achieved a DBP response and 76.9% achieved a SBP response rate.(a)

(a) Response: DBP (less than) 90 mmHg or (greater than or equal to) 10 mmHg reduction from baseline; SBP (less than) 140 mmHg or (greater than or equal to) 10% reduction from baseline.

Study Supports Benefits of Chronotherapy

Statistics show that the incidence of sudden cardiac death, myocardial ischemia, stroke and myocardial infarction increases in the early morning hours. Verelan PM uses the proprietary Chronotherapeutic Oral Drug Absorption (CODAS(TM)) technology, which incorporates a four-to-five hour delay in drug delivery. This extended-release, controlled-onset drug delivery system results in a maximum plasma concentration of verapamil during these early-morning hours when prescribed as a once daily bedtime dosage.

"The medical community is beginning to appreciate the importance of a patient's natural body rhythms as they relate to timing of medications," said Ron Stratton, President and Chief Operating Officer, Schwarz Pharma Inc., marketer of Verelan PM. "Cardiovascular researchers have known for some time that blood pressure increases rapidly in the early morning as a person wakes and begins activity."

The clinical significance of reducing the early-morning rise in blood pressure has not been established. Verapamil should be administered cautiously in patients with impaired renal or hepatic function. Headache, constipation, peripheral edema, and dizziness were among the most common side effects. For complete prescribing information, please visit our website at www.schwarzusa.com.

SCHWARZ PHARMA AG is a pharmaceutical company strategically positioned in the industry to focus on the development and marketing of innovative therapeutics. Schwarz Pharma uses its experience and trade record to secure new product flow through collaborative alliances with academia, research organizations, biotech, pharmaceutical and drug delivery companies. This development strategy is supported and funded by the established position of SCHWARZ PHARMA as a global pharmaceutical company with a marketing presence in all key international markets.

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