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Developing Flutiform to Satisfy Markets and Regulatory Requirements Worldwide

Venthoye G, Kaiser K.

Respiratory Drug Delivery 2012. Volume 1, 2012: 161-168.

Abstract:

Flutiform™ pMDI (“Flutiform”) is a fixed combination product for the treatment of persistent asthma that delivers the inhaled corticosteroid (ICS) fluticasone propionate, and the long-acting β2-agonist (LABA) formoterol fumarate dehydrate, by oral inhalation via a hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI). Flutiform is in the advanced stages of development and registration worldwide and has been developed by SkyePharma in collaboration with its licensees, Mundipharma (Europe and Rest of World [ROW] ex-Americas), Kyorin (Japan), Sanofi (LATAM), and former licensee, Abbott (US). The global development of Flutiform has highlighted important insights into the development of inhaled fixed combination products to meet the requirements of different territories, including the established major markets (US, EU, and Japan), as well as the growing emerging markets. From an initial core US-centric program, distinct development programs for each territory were conducted in collaboration with the licensees. Each program required special consideration of various country specific factors, such as the regulatory and clinical requirements, prescribing practices, and the cost and reimbursement of medication. The influence of these factors on the target product profile and chemistry, manufacturing and controls (CMC) aspects was evaluated during the course of developing the product for each territory. The different regulatory requirements particular to inhaled combination products, especially the demonstration of efficacy and safety for products containing an ICS and a LABA, were found to have the greatest impact. These differences were manifested in the development of specific strengths and presentations for certain markets, and for the US, in the preparation of mono-component comparator products, fluticasone pMDI and formoterol pMDI.