PHILADELPHIA, March 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the new drug application (NDA) for Coreg CR(TM) 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(R) (carvedilol). COREG CR was developed with Flamel Technologies’ Micropump(R) 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.”
About COREG
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.
Specific indications for COREG are:
* COREG is approved for the treatment of hypertension, which is also known
as high blood pressure.
* COREG is approved to reduce the risk of death in patients who suffered a
heart attack that reduced how well the heart pumps.
* COREG is approved to increase survival in mild to severe heart failure
patients.
Important Safety Information
It is important for patients to take their medicine every day as directed by their doctors or health care providers. Patients taking COREG should avoid stopping therapy abruptly. With certain beta-blocking agents, stopping therapy abruptly has led to chest pain and, in some cases, heart attack. If their doctor decides that they should stop taking COREG, their doctor or health care provider may slowly reduce their doses over a period of time before stopping it completely.
Some common side effects associated with COREG include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension, dizziness or faintness. People taking COREG who have any of these symptoms should call their doctor. Additionally, if patients experience fatigue or dizziness, they should sit or lie down and avoid driving or hazardous tasks. Beta-blockers may mask the symptoms of low blood sugar or alter blood sugar levels. People with diabetes should report any changes in blood sugar levels to their physician. Contact lens wearers may produce fewer tears or have dry eyes. As with any medicine, patients taking COREG should also first tell their doctor what other medications they are taking.
As with any medicine, there are some people who should not take COREG. The people who should not take COREG include those with severe heart failure who are hospitalized in the intensive care unit. Also, people who require certain intravenous medications that help support their circulation (inotropic medications) should not receive COREG. Other people who should not take COREG are those who are prone to asthma or other breathing problems, those with a very slow heartbeat or heart that skips a beat (irregular heartbeat) and those with liver problems. For more information on COREG, visit http://www.coreg.com.
About GlaxoSmithKline
GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Customer information line: 1-888-825-5249 Web site address: http://www.gsk.com.
GlaxoSmithKline
CONTACT: Robert Perry of GlaxoSmithKline, +1-919-483-2839; or Ben Klein,Onsite, of Cohn & Wolfe, +1-516-996-5995 for GlaxoSmithKline
Web site: http://www.gsk.com/http://www.coreg.com/
