Pediatric medicines: a brief overview with a focus on drug reformulation and repositioning

INTRODUCTION: Developing medicines for pediatric patients remains a significant challenge, related to the wide age range included in the pediatric population, the complex design of clinical trials in children and the limited economic benefits for companies due to the small pediatric market, which results in the current scarcity of pediatric therapies. AREAS COVERED: In this framework, a brief overview regarding pediatric pharmaceutical forms and current practices as manipulation and off-label use is provided as an introduction. The aim of this narrative review is to provide insight into addressing the lack of pediatric medications through various approaches. Firstly, the regulatory landscape and the incentives promoted by regulatory agencies are presented, mainly focusing on legislation provided by FDA and EMA. Subsequently, the advantages of drug reformulation and drug repurposing are explored, by analyzing the underlying fundamentals, their potential applications, and any specific regulations. Literature search was conducted by examining publications from the last 20 years. EXPERT OPINION: In conclusion, future developments and areas for improvement are discussed, to raise awareness about ways to contribute to the advancement of pediatric medicine.