Pharmaceutical Business review

GSK wins approval for extended release heart drug

Coreg CR will utilize Flamel's Micropump technology, which controls the amounts of medicine in the body over a 24 hour period. This technology allows Coreg CR to be dosed once daily, in contrast to immediate-release Coreg tablets, which patients must take twice daily.

“Once-a-day Coreg CR will simplify the treatment regimen and offer the potential for improved compliance for patients with heart disease,” said Michael Weber, professor of medicine, at the SUNY Downstate Medical College of Medicine in New York

Coreg CR is a third generation “beta blocker,” which is a class of medicines that work by slowing heart rate and lowering the force with which it pumps.

Evidence of the treatment benefits of Coreg CR has come from multiple clinical studies. The trial of more than 3,000 heart failure patients demonstrated that patients receiving Coreg CR lived 1.4 years longer compared to patients taking the beta blocker metoprolol tartrate. In another study focused on hypertension Coreg effectively lowered blood pressure while having a neutral impact on blood-sugar levels, lipids and weight gain.

GlaxoSmithKline plans to begin shipping Coreg CR in the first quarter of 2007.