Merck's NDA for Cordaptive (ER niacin/laropiprant), formerly known as MK-0524A, has been accepted for review by the FDA. Cordaptive is an investigational drug containing Merck's extended-release niacin and laropiprant, a flushing pathway inhibitor designed to reduce flushing associated with niacin treatment.
The application supports the 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.
Merck anticipates FDA action in 2Q2008. The company is also moving forward with filings outside the U.S.
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