New pediatric formulation of Praziquantel, which Astellas Pharma Inc. (“Astellas”) provided its formulation technology and has been developed under the initiative of Merck together with its consortium partners, has now been completed its pivotal Phase 3 trial. The favorable results of this clinical trial allow the program to progress towards regulatory file submission to the European Medicines Agency (EMA).
The existing praziquantel tablet is the “standard of care” treatment for schistosomiasis, which is one of the most prevalent parasitic diseases in developing countries. As it is not suitable for the treatment of pre-school aged children because of its large size and bitter taste, those children have been untreated.
To solve these problems, the new pediatric formulation has been developed with Astellas’ formulation technology. This new formulation is a smaller and orally dispersible tablet. It has reduced bitterness that can be taken with or without water. The pediatric formulation has also been designed for production using simple manufacturing processes and 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.
This activity is funded by the Global Health Innovative Technology Fund (GHIT Fund) and The European & Developing Countries Clinical Trials Partnership (EDCTP).
For details on the completion of this Phase 3 clinical trial, please see the Press Release from PEDIATRIC PRAZIQUANTEL CONSORTIUM.
For more information on Astellas’ contribution for the development of the Praziquantel, please see (https://www.astellas.com/jp/en/sustainability/development-of-pediatric-formulation-for-schistosomiasis)