Kos Pharmaceuticals, Inc. has been issued US Patent No. 6,818,229, entitled "Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia" by the United States Patent and Trademark Office (USPTO).
The '229 patent, Kos' sixth patent for its Niaspan-based cholesterol franchise, covers certain biopharmaceutical characteristics. Specifically, the patent covers ranges for Cmax (maximum blood concentration), Tmax (time to reach maximum concentration in blood) and AUC (area under the curve) that confer clinically proven safety and tolerability profiles for an extended release niacin formulation. These characteristics are properties of Niaspan and Advicor, Kos' other marketed cholesterol drug.
"This new patent further validates the extensive clinical research we have conducted to date on the safety, efficacy and tolerability features of Niaspan," commented Adrian Adams, president and CEO.
Niacin has been known for decades to be an effective cholesterol medication at high doses, but was limited by significant side effects. Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, to reduce elevated total cholesterol, LDL-C (Low-Density Lipoprotein; "bad" cholesterol), Apo B, and triglycerides (TG) levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. Additionally, Niaspan is also indicated to reduce the risk of recurrent heart attacks in patients who have a history of heart attack and hypercholesterolemia.