Absorica™ is an innovative formulation of the active ingredient isotretinoin, which is used in the treatment of severe recalcitrant nodular acne. Isotretinoin is the most effective severe acne therapy available to teenagers who suffer from acne.
Product Overview
Absorica™ is based on the same oral Lidose® drug delivery system used with CIP-FENOFIBRATE. A major issue for existing isotretinoin products is patient compliance, as the active ingredient should be taken with a high-fat meal to ensure consistent absorption. Teenage eating habits are typically irregular compared to working-age adults Absorica™ has been proven to provide a more consistent absorption under fed and fasted conditions, compared to existing isotretinoin products that exhibit a 65% reduction in absorption under fasted conditions.
Absorica™ received final approval from the U.S. FDA on May 25, 2012. The Company has a distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("RPI"), under which Cipher granted RPI the exclusive right to market, sell and distribute Absorica™ in the United States, and was launched in November.
The product received approval by Health Canada in November 2012. Cipher expects to launch it as Epuris™ in Canada in early Q3 2013.
Market Overview
According to IMS the U.S. isotretinoin market was approximately $0.5 billion in 2011, and if converted into brand dollars, is estimated to be more than US$0.8 billion in annual sales.