CIP-ISOTRETINOIN is an innovative formulation of the active ingredient isotretinoin, which is used in the treatment of severe acne. Isotretinoin is the most effective severe acne therapy available to teenagers that suffer from acne.
Product Overview
CIP-ISOTRETINOIN is based on the same oral Lidose® drug delivery system used with CIP-FENOFIBRATE. In Phase I clinical studies, Cipher’s innovative formulation demonstrated a significant competitive advantage in the treatment of severe, recalcitrant nodular acne. 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. CIP-ISOTRETINOIN 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. CIP-ISOTRETINOIN offers more consistent absorption day-in and day-out over the course of a typical 3- to 5-month treatment period.In August 2008, the Company achieved a major milestone with the completion of a distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. (“RPI”), under which Cipher granted RPI the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States.
In Q2 2011 Cipher completed its pivotal Phase III safety trial for the product. The study, which was conducted under an FDA Special Protocol Assessment, was a randomized double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product.The safety, efficacy, and population pharmacokinetic data generated from this study, together with previously submitted data, will be used to complete a revised NDA being prepared for submission to the FDA in Q4 2011. The FDA review of this submission under PDUFA is expected to be six months. A regulatory submission to Health Canada is also planned for Q4 2011.