Development of Pediatric Formulation for Schistosomiasis
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Schistosomiasis is one of the most prevalent parasitic diseases in developing countries, notably in Africa and South America. The economic and health impacts of schistosomiasis are considerable. If it is left untreated, schistosomiasis causes anaemia, stunted growth, reduced ability to learn, and chronic inflammation of the organs, which can be fatal*1. The disease has a particularly high incidence among children.
The existing “standard of care” treatment for schistosomiasis is praziquantel. However, at present, the group of infected preschool-age children, including infants and toddlers, is left untreated in public health programs due to lack of relevant clinical data and a missing appropriate child-friendly formulation of the drug. Young children cannot swallow the existing tablet because of its large size and bitter taste.
Within a consortium of partners, involving pharmaceutical companies, research institutions and international non-profit organizations, Astellas has developed a pediatric formulation of praziquantel.
The pediatric formulation newly developed by Astellas uses proprietary drug formulation technology to create a smaller, orally dispersible tablet of reduced bitterness that can be taken with or without water. The pediatric formulation has also been designed for manufacturing at reduced cost using simple production technology, yielding tablets that are stable even in hot and humid tropical climates. To facilitate production of materials for clinical trials and help build local pharmaceutical manufacturing capabilities for future supplies, Astellas has transferred to consortium partners in Germany and Brazil the technology and expertise needed to develop the pediatric formulations and produce the tablets.
After successful completion of the Phase II clinical study, the consortium program is currently running the pivotal Phase III clinical trials in Kenya and Ivory Coast to gain data for registration and facilitate access to a novel orally dispersible tablet formulation for young children (below six years of age). Astellas is committed to providing the consortium with all necessary technical expertise. As a member of the consortium, Astellas is working with the partners aiming to have the product available for launch in the first endemic country in Africa in a few years.