Abbott received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin-the most commonly prescribed dose of simvastatin – with either 500 mg or 1,000 mg of niacin extended-release. SIMCOR is the first treatment to combine Abbott’s proprietary niacin extended-release and simvastatin, the most commonly used statin.
SIMCOR is a prescription medication used along with diet in people who cannot control their cholesterol levels by diet and exercise alone. SIMCOR is approved to raise HDL “good ” cholesterol and lower levels of elevated total cholesterol, LDL ” bad” cholesterol and triglycerides. SIMCOR is a combination medicine used when treatment with simvastatin alone or niacin extended-release alone is not considered adequate. No additional benefit of SIMCOR on heart disease over and above that shown for simvastatin alone and niacin alone has been demonstrated.
“Approval of the new SIMCOR dosage strengths means that physicians and patients now have more options to treat complex lipid disease,” said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.
SIMCOR was approved by the FDA in February 2008 in the following strengths: 500/20 mg, 750/20 mg and 1,000/20 mg. The original FDA approval was supported by results from the SEACOAST trial, which demonstrated efficacy and safety of SIMCOR up to doses of 2,000 mg niacin extended-release / 40 mg simvastatin daily in patients with mixed dyslipidemia and type II hyperlipidemia. The SIMCOR 40 mg strengths will be available in early August 2010.
Treatment guidelines endorsed by the National Cholesterol Education Program, the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for some patients, as well as more aggressive management of HDL and triglycerides.
Date: July 28, 2010
Filed Under: Drug Discovery