Novel form of fenofibrate wins approval

January 30, 2006

Cipher Pharmaceuticals has received a thumbs-up from the FDA for Lipofen (CIP-fenofibrate) for the treatment of hyperlipidemia. The new drug is the first product from Cipher to receive approval, and the formulation is based on the company's Lidose delivery system, used to increase the extent of absorption under high-fat conditions relative to low-fat conditions. Lipofen is available in three dosage strengths-50, 100, and 150 mg. According to Cipher, the 150-mg strength is equivalent to Abbott's Tricor 160-mg tablets. The drug is approved as adjunctive therapy to diet to reduce elevated LDL cholesterol, total cholesterol, triglycerides, apolipoprotein B, and to increase HDL cholesterol in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Type IIa, IIb), in addition to the treatment of adult patients with hypertriglyceridemia (Frederickson Types IV and V hyperlipidemia).