Clinical Pharmacologist BMS, New Jersey, United States
Background: Food effect (FE) studies are essential for understanding a drug's safety and efficacy. Still, ethical concerns prevent them from being conducted on pediatric patients, resulting in limited FE data for this population. According to USFDA guidelines, FE studies can be performed using new pediatric formulations in adults, which can be extended to pediatric patients. This study aims to identify oral drug products approved for pediatric use (birth to 18 years) between 2004 and 2024, with FE observed in adults or pediatrics. Methods: To identify oral drugs approved for pediatric patients (birth to 18 years), various publicly available databases such as FDA clinical pharmacology reviews, medical reviews, and product labeling were used. Vivpro and the US FDA database were employed to review FDA-approved drug submissions from 2004 to 2024 with food labeling information. The following information was collected for each drug: a. Approval year, b. Dosage form, c. Approved pediatric age/weight range, d. Therapeutic category, e. BCS class, f. Formulation and g. PK parameters (if available). Results: Of the 104 oral drug products approved for use in pediatric patients, 44 recommended considering food intake in the drug labeling. The most common therapeutic categories with FE studies were antivirals and neurologic drugs. Most drugs with specific food intake instructions were classified as either BCS class II or BCS class III. Tablets were the most common formulation employed in the food effect studies, whereas capsules were the least favorable formulation. Conclusion: Our findings confirmed that most of the FE studies intended for pediatric patients are conducted in adult population using new pediatric formulations in adults and then extended to pediatric population as described in FDA guidelines. However, novel methods are needed to accurately assess FE interactions in the pediatric patients due to differences in ontogeny, diet and physiology.
