Schistosomiasis is one of the most prevalent parasitic diseases in developing countries, notably in Africa and South America. 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.
Having set up a consortium with other pharmaceutical companies, research institutions and international non-profit organizations, Astellas is developing 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 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, Astellas has transferred to consortium partners in Brazil and Germany the technology and expertise needed to develop the pediatric formulations.
After successful completion of Phase II clinical studies, the consortium program is currently preparing for Phase III clinical trials to gain registration and facilitate access to a novel orally dispersible tablet formulation for children. Astellas is committed to providing the consortium with all necessary technical expertise.
Newly developed pediatric formulation (top) and existing tablet (bottom)
Pediatric Praziquantel Consortium partners and project contributors|
©Global Health Innovative Technology Fund
※This movie was created by GHIT Fund on July 2019