Merck & Co., Inc. announced that the New Drug Application (NDA) for Cordaptive (ER niacin/laropiprant), formerly known as MK-0524A, has been accepted for standard review by the US Food and Drug Administration (FDA). Merck anticipates FDA action in the second quarter of 2008. The company is also moving forward as planned with filings in countries outside the United States.
Cordaptive is an investigational compound containing Merck's own extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. Data included in the application support the proposed use of Cordaptive, either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol (LDL-C or "bad" cholesterol), low HDL cholesterol (HDL-C or "good" cholesterol) and elevated triglycerides levels. All are conditions associated with increased risk of heart disease.
Niacin is widely recognized as an effective lipid-modifying therapy; however, treatment has been limited as a result of the flushing side effect.
The company expects to present phase III data for Cordaptive at both the September 2007 Scientific Meeting of the European Society of Cardiology and the November 2007 Scientific Meeting of the American Heart Association.