Paediatric drug optimization for epilepsy: meeting report, 1-2 July 2025
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World Health Organization
Abstract
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iv, 27 p.
Epilepsy represents a significant global neurological burden affecting millions of children, with persistent gaps in access to appropriate treatment and age-adapted medicines, particularly in low- and middle-income settings. Within the framework of WHO efforts to accelerate access to optimal paediatric formulations, including the Global Accelerator for Paediatric Formulations (GAP-f), this meeting report presents the outcomes of a paediatric drug optimization (PADO) exercise focused on epilepsy. The document examines current antiseizure medicines, their suitability for paediatric use and key barriers related to availability, affordability and formulation, drawing on a structured review of WHO guidance, including the Model List of Essential Medicines for Children, expert consultation and analysis of the research and development pipeline . It describes consensus-based access, priority and watch lists intended to guide development, regulatory consideration and procurement, and outlines priority research questions, including the need for earlier inclusion of children in clinical trials and improved formulation design. Intended for policymakers, researchers, manufacturers and global health stakeholders, the findings highlight the importance of coordinated action to expand equitable access to safe, effective and child-appropriate epilepsy treatments.
Epilepsy represents a significant global neurological burden affecting millions of children, with persistent gaps in access to appropriate treatment and age-adapted medicines, particularly in low- and middle-income settings. Within the framework of WHO efforts to accelerate access to optimal paediatric formulations, including the Global Accelerator for Paediatric Formulations (GAP-f), this meeting report presents the outcomes of a paediatric drug optimization (PADO) exercise focused on epilepsy. The document examines current antiseizure medicines, their suitability for paediatric use and key barriers related to availability, affordability and formulation, drawing on a structured review of WHO guidance, including the Model List of Essential Medicines for Children, expert consultation and analysis of the research and development pipeline . It describes consensus-based access, priority and watch lists intended to guide development, regulatory consideration and procurement, and outlines priority research questions, including the need for earlier inclusion of children in clinical trials and improved formulation design. Intended for policymakers, researchers, manufacturers and global health stakeholders, the findings highlight the importance of coordinated action to expand equitable access to safe, effective and child-appropriate epilepsy treatments.
Keywords
Epilepsy, Anticonvulsants, Pediatrics, Drug Design, Drug Therapy, Drugs, Essential, Drug Development, Pharmaceutical Preparations, Drug Compounding, Drug Development, Dosage Forms, Child, Infant, Adolescent, Drug Evaluation, Developing Countries, Innovation, Technology Assessment, Biomedical, Product Surveillance, Postmarketing, Pharmacology, Clinical, Nervous System Diseases, Seizures, Meeting Abstract, therapeutic use, drug therapy, methods, administration and dosage