The combination drug contains Merck-developed extended-release niacin and laropiprant – a novel flushing pathway inhibitor. Cordaptive lowered LDL-cholesterol (LDL-C) levels, increased HDL-cholesterol (HDL-C) levels and reduced triglyceride levels compared to placebo. Patients treated with Cordaptive also reported significantly less flushing compared to those patients treated with extended-release niacin alone.
Across weeks 12 to 24 of the study, two grams (two one-gram tablets) of Cordaptive produced significant percent changes from baseline in LDL-C levels (-18%), HDL-C levels (20%) and triglyceride levels (-26%) relative to placebo. In addition, patients treated with Cordaptive reported significantly less flushing both at the initiation of therapy and during maintenance therapy, compared to patients on extended-release niacin alone.
Merck has already submitted a new drug application to the FDA and anticipates a decision in the second quarter of 2008. The company added that it is also moving forward as planned with filings in countries outside the US.