Programme européen (O3K) de formulations orales pédiatriques

A. Paci Institut Gustave Roussy, Villejuif, France

There is an urgent need for appropriate oral formulations of anticancer drugs for the treatment of paediatric malignancies in children of all ages. The goal of the O3K consortium is to develop oral liquid formulations of Cyclophosphamide and Temozolomide, important chemotherapeutics which have been identified in the list of paediatric needs by European MEdicines Agency (EMEA/197972/2007).

Both off-patent drugs are widely used orally for the treatment of childhood cancer. However, the currently available tablets (Cyclophosphamide) and capsules (Temozolomide) are not suitable for use in a paediatric setting, particularly in infants and young children, as it is often impractical for them to be swallowed. This is a major health concern since these children do not readily have direct and safe access to these curative drugs. The NODS® technology represents an innovative oral drug delivery system for drinkable products for children. Drug entrapment in NODS® particles provides gastroprotection, stabilization, chemical protection of labile compounds and taste masking.

O3K will conduct the pharmaceutical, clinical and pharmacological studies required for the development of these oral liquid formulations. Upon completion of the project, a dossier containing data required for application for a Paediatric Use Marketing Authorisation (PUMA) will be filed for both products. The EMEA Scientific Advice is already ongoing. O3K will provide access to curative drugs for all children with cancer, improving compliance, ensuring safety for both patient and environment and allowing the development of essential ambulatory treatments.

In accordance with ICH guidelines, the development of these agents will lead to improved quality and safety of paediatric drug formulations. The O3K project involves 9 partners (including 5 institutions and 3 SMEs providing significant expertise in clinical and pharmacological research relating to paediatric oncology along with 1 parents organisation) from three European member states (UK, Italy and France.

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