Kos' Niaspan Cleared In Its First Market

In the USA, Kos Pharmaceuticals of Miami, Florida, has been granted Foodand Drug Administration approval to market Niaspan, a "once-a-night" formulation of niacin, for the treatment of mixed lipid disorders. It is the first niacin product to be labeled for reducing the risk of nonfatal recurrent myocardial infarction and regressing atherosclerosis when used in combination with bile-binding resins.

Niacin is considered a very good drug for lowering plasma lipids, but it has unwanted side effects which have limited its widespread use, including flushing and liver toxicity. Its improved formulation has meant that in trials, less than 6% of patients discontinued therapy because of liver enzyme elevations, and less than 1% discontinued because of flushing.

Furthermore, Niaspan offers improved efficacy and drives all lipid fractions in the right direction, says Kos. Its night-time administration (the company has even trade-marked the "once-a-night" strap-line) coincides with the peak for cholesterol synthesis in the body, and this is thought to contribute to its effects on lipids. Trials have shown that, on average, the drug can achieve low-density lipoprotein-cholesterol reductions of up to 17%, reduce triglycerides by up to 35%, reduce lipoprotein(a) by up to 24% and increase high-density lipoprotein cholesterol by up to 26%.