Business Wire - Biovail Submits Cardizem LA NDA for Angina
Business Editors/Health/Medical Writers
TORONTO–(BUSINESS WIRE)–July 2, 2003
Biovail Corporation (NYSE, TSX: BVF) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for an angina indication for Cardizem(R) LA. Biovail launched Cardizem LA, a once-daily oral graded-release diltiazem formulation used in the treatment of hypertension, in the United States on April 2, 2003. Cardizem LA belongs to the family of medications called Calcium Channel Blockers.
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“Once Cardizem LA is approved for the treatment of angina, physicians will have greater flexibility in treating their angina patients with the once-daily formulation of this well-known and well-respected medication,” commented Eugene Melnyk, Chairman and CEO of Biovail Corporation. “Prescription numbers for the recently launched Cardizem LA indicate physician acceptance of this graded-release medication in treating their patients with hypertension. We believe Cardizem LA will provide an important new treatment option for their angina patients.”
Angina pectoris (also referred to as angina) is a recurring pain or discomfort in the chest that happens when some part of the heart does not receive enough blood. It is a common symptom of coronary heart disease, which occurs when vessels that carry blood to the heart become narrowed and blocked due to atherosclerosis.
Angina is often controlled by drugs. The choice of drug is usually dependent on the acuity and severity of the patient as well as the presence of other existing conditions. Calcium channel blockers (CCBs) are effective in reducing the frequency and severity of angina attacks. In many patients a combination of agents is more effective than therapy with only one medication.
According to NDTI (The National Disease and Therapeutic Index), CCBs are used in 16% of patients with angina and hypertension. Diltiazem is used in 30% of these cases. CCBs are used in nearly 8% of patients who have angina without hypertension and diltiazem is used in 35% of these instances.
Clinical Trial Information
The sNDA application is based upon the results of a Phase III trial that was presented at the American College of Cardiology meeting on March 30, 2003. In this double-blind, placebo-controlled study, 311 patients with chronic exercise induced angina confirmed by baseline treadmill stress tests, were randomized to either placebo, nighttime doses of Cardizem LA of 180mg, 360mg or 420mg, or a morning Cardizem LA dose of 360mg. Treadmill stress tests were repeated at endpoint. The primary efficacy variable was the change in total duration of exercise from baseline to endpoint at trough. Key secondary variables were change in time to onset of angina from baseline to endpoint and time to onset of silent myocardial ischemia as measured by at least 1mm ST segment depression in the ECG tracing. Treadmill stress tests were done at two different time periods, between 6PM to 8PM and 7AM to 11AM. These time intervals were selected to measure the effects of various dosing schedules at peak (when blood levels of medication are highest) and at trough (when blood levels are lowest just prior to the next dose administration).
For the primary efficacy variable, total duration of exercise at trough, all nighttime doses were statistically significantly superior to placebo. In contrast, the increase in total duration of exercise by the morning dose approached, but did not achieve statistical significance. The efficacy of 360mg dosed at night was approximately two-fold greater compared to the same dose given in the morning.
Between 7AM to 11AM, when the incidence of angina attacks is greatest, nighttime dosing doubled exercise tolerance compared to morning dosing. Similar results favoring PM dosing were demonstrated for other key measures of efficacy, time to onset of angina and time to onset of silent ischemia. More than 50% of patients randomized to 420mg PM never experienced an angina attack.
Adverse events were generally mild to moderate in nature and comparable to placebo even at the highest dose.
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.
For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.
“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995.
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission.
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