Cipher Pharmaceuticals Inc. has received final approval from the US Food and Drug Administration for CIP-Fenofibrate, the company's novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia. CIP-Fenofibrate, approved under the label as Lipofen, targets a large and growing market as the three existing novel fenofibrate formulations are forecasted to exceed $1 billion in annual US sales.
"CIP-Fenofibrate is the first product from our pipeline to successfully receive FDA approval and we are actively pursuing opportunities to secure a US commercial distribution agreement," said Larry Andrews, president of Cipher Pharmaceuticals.
"CIP-Fenofibrate is one of three late-stage products in our pipeline. With an application for CIP-Isotretinoin under review with the FDA and preparations underway to file the CIP-Tramadol application with the FDA in the first half of 2006, we believe that the approval of CIP-Fenofibrate represents the first of a number of significant milestone events for Cipher," added Andrews.
CIP-Fenofibrate received approval for three unique fenofibrate dosages: 50, 100 and 150 mg, with the 150 mg strength equivalent to Tricor 160 mg under fed conditions. With CIP-Fenofibrate, the extent of absorption is increased under high-fat conditions relative to low-fat conditions, claims a Cipher release.
The approval provides for the use of CIP-Fenofibrate as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total-cholesterol (Total-C), triglycerides, apolipoprotein B (Apo B), and to increase high-density lipoprotein (HDL-C) 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).
Cipher Pharmaceuticals is a drug development company focused on commercialising novel formulations of successful, currently marketed molecules using advanced drug delivery technologies.