GSK, FLAMEL'S ONCE-A-DAY COREG CR WINS FDA APPROVAL

GlaxoSmithKline (GSK) and Flamel Technologies have announced FDA approval of their once-a-day Coreg CR (carvedilol phosphate) extended-release capsules for the treatment of high blood pressure, post-myocardial infarction and mild to severe heart failure.

Coreg CR uses Flamel's proprietary Micropump technology, which controls the delivery of carvedilol helping to maintain appropriate amounts of medicine in the body over a 24-hour span. This technology allows the drug to be dosed once daily, in contrast to immediate-release Coreg tablets, which patients must take twice daily. Coreg CR will be available in 10-, 20-, 40- and 80-mg dosage strengths.

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. Studies indicate it is generally well-tolerated with a low incidence of adverse events. Coreg CR is approved to treat the same conditions as twice-a-day Coreg, which has established a significant role in the treatment of heart disease.

Evidence of the treatment benefits of Coreg has come from multiple clinical studies. COMET, published in 2003, was a trial of more than 3,000 heart failure patients that demonstrated patients receiving Coreg lived 1.4 years longer compared with patients taking the metoprolol tartrate. Important insights into the effect of Coreg following a heart attack came from the CAPRICORN trial, published in 2001. This study showed that patients taking Coreg had a significantly reduced risk of having another heart attack. Another study, GEMINI, in 2004, evaluated patients with hypertension and underlying diabetes. Results showed that Coreg effectively lowered blood pressure while having a neutral impact on blood-sugar levels, lipids and weight gain.