FDA approves Biovail's Cardizem LA for hypertension
FDA approves Biovail's Cardizem LA for hypertension
TORONTO, CANADA, Feb. 7, 2003 -- Biovail Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Cardizem LA, a new graded extended-release formulation of diltiazem HCl for the treatment of high blood pressure or hypertension.
Cardizem LA (Long Acting) provides 24-hour blood pressure control with a single daily dose and a flexible dosing range from 120mg to 540mg. Cardizem LA is the only product labeled to allow administration in either the morning or the evening.
With evening administration and the unique graded release technology, clinical trials have shown increased reduction in blood pressure in the early morning hours, which is when patients may be at greatest risk of significant cardiac events.
"Cardizem LA is the first New Drug Application (NDA) product that Biovail will launch directly to physicians using our own fully-integrated sales force in the United States," stated Eugene Melnyk, Chairman and CEO of Biovail. "The introduction of Cardizem LA offers physicians a once daily formulation of the compound diltiazem, a drug that is well-regarded for its safety profile and one with a brand name that physicians have come to know and trust."
Clinical studies indicate that morning or evening dosing of Cardizem LA provides effective 24-hour blood pressure control.
"Uncontrolled hypertension plays a significant role in the deaths of hundreds of thousands of heart-disease patients in the U.S. each year,(1)" said Joel Neutel, MD, assistant clinical professor, University of California at Irvine. "With the approval of Cardizem LA, we now have a proven therapy that provides effective and safe 24-hour blood pressure control with potential added benefits for patients with specific hypertensive risks."
Approximately 50 million American adults -- or one in four -- have high blood pressure, and 25 percent of these are not adequately treated. Uncontrolled hypertension kills 430,000 Americans each year and contributes to the deaths of 210,000 others.
In two randomized, placebo-controlled clinical trials, Cardizem LA demonstrated dose-related mean reductions in trough diastolic blood pressure (DBP) following evening administration of 120mg, 240mg, 360mg and 540mg doses when compared to placebo. Reductions ranged from -2.0 millimeters of mercury (mm/Hg) with the 120mg dose to -8.1mm/Hg with the 540mg dose. A similar range of morning doses showed a linear decrease in DBP from -1.9mm Hg with a 120mg dose to -8.6mm/Hg with 540mg. All doses above 120mg maintained their anti-hypertensive effect for a complete 24-hour period. Side effects at dosages up to 540mg were similar to placebo.
"The data demonstrate that Cardizem LA delivers 24-hour blood pressure control whether dosed in the morning or the evening," said Stephen Glasser, MD, professor of epidemiology at the University of Minnesota, School of Public Health. "We continue to explore the clinical significance of the blood pressure effect of evening Cardizem LA administration and have seen favorable clinical trial results in the treatment of angina."
The most commonly reported side effects with Cardizem LA were headache, edema and upper respiratory tract infection. Side effect incidence was similar to placebo.
Cardizem LA should not be used by patients who have abnormal heart rhythms due to sick sinus syndrome or very slow heartbeats as a result of second- or third-degree AV block, except in the presence of a functioning ventricular pacemaker. Patients should also avoid Cardizem LA if they have hypotension (less than 90mm/Hg systolic blood pressure), hypersensitivity to diltiazem or acute myocardial infarction and pulmonary congestion confirmed by x-ray.
Cardizem LA will be launched in doses of 120mg, 180mg, 240mg, 300mg, 360mg and 420mg. Dosing up to 540mg has been approved by the FDA and Biovail currently has a single dose 540mg product under development. Biovail expects to launch Cardizem LA commercially on April 2, 2003.
(1) Philadelphia Inquirer. Nov. 13, 2002: A01.
Source: Biovail, Inc.
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