GlaxoSmithKline's new drug application (NDA) for Coreg CR has been accepted for review by the US 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.
According to a GSK release, data presented at 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.
"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," Michael A. Weber, professor of medicine, at the SUNY Downstate Medical College of Medicine, Brooklyn, New York said adding, "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."
Coreg is marketed by GlaxoSmithKline in the United States and is the only beta-blocking agent that is FDA approved to improve survival in mild to severe heart failure and is the only beta-blocker approved for patients who suffered a heart attack that reduced how well the heart pumps.