GSK’s Coreg accepted for review by FDA

Coreg CR is the controlled release formulation of the already marketed Coreg. The new formulation 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.

Data presented at the 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. If approved, Coreg CR would be available to patients in a once-a-day dose, as opposed to the twice-a-day formulation of the drug currently available.

“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 Dr Michael Weber, professor of medicine, at the SUNY Downstate Medical College of Medicine, 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.”