GlaxoSmithKline receives NDA for Coreg CR

Mar 17 2006

GlaxoSmithKline has announced that the new drug application (NDA) for Coreg CR has been accepted for review by the U.S. Food and Drug Administration (FDA).

COREG CR (carvedilol phosphate controlled-release capsules) is the controlled release formulation of the immediate-release beta-blocker Coreg (carvedilol). COREG CR was developed with Flamel Technologies' Micropump technology and is designed to control dissolution and absorption of COREG in the body, allowing for once a day dosing. The NDA was submitted on December 21, 2005.

Data presented at this week's American College of Cardiology 55th Annual Scientific Session show that COREG CR was superior to placebo in reducing blood pressure over the full 24-hour dosing interval. Once approved, COREG CR would be available to patients in a once-a-day dose. The formulation of COREG currently available is dosed twice-a-day.

The double-blind, randomized, placebo-controlled, parallel group, multi- center study compared three doses of COREG CR to placebo in patients with hypertension who may or may not have been taking other blood-pressure lowering medications. Patients enrolled in the study had an average 12-hour daytime diastolic blood pressure by ambulatory blood pressure monitoring (ABPM) of greater than or equal to 90 mmHg, but less than or equal to 109 mmHg. The effects on blood pressure of COREG CR were evaluated using 24-hour ABPM in people with essential hypertension.

Patients were randomized to receive once-daily doses of COREG CR 20 mg, 40 mg, 80 mg or placebo for six weeks. Diastolic blood pressure was lowered by 4.4 mmHg, 7.9 mmHg and 9.6 mmHg in the COREG CR 20, 40 and 80 mg treatment groups, respectively, compared to a -0.4 mmHg change for placebo (P<0.0001 for each dose of COREG CR compared to placebo). COREG CR also reduced systolic blood pressure in a dose-dependent manner over the 24-hour period. COREG CR was generally well tolerated in the study.

"This study showed that the new extended release formulation of carvedilol provided clinically meaningful blood pressure reductions in a dose-dependant manner for a 24-hour span," said Michael A. Weber, M.D., professor of medicine, at the SUNY Downstate Medical College of Medicine, Brooklyn, New York. "This blood pressure effect is noteworthy in light of guidelines recommending the use of long-acting medications that provide 24-hour efficacy to minimize blood pressure variability."