De Novo Pediatric Development of an Antiviral Drug Product: A Perspective from Industry
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0092-8615/99 Copyrighr 0 1999 Drug Information Association Inc.
DE NOVO PEDIATRIC DEVELOPMENT OF AN ANTIVIRAL DRUG PRODUCT: A PERSPECTIVE FROM INDUSTRY JON M. ROGERS,MD Vice President, Clinical Research, ViroPharma Incorporated, Exton, Pennsylvania
The evaluation of a new chemical entity for use in pediatric populations, while normally a development ajierthought, can be successfully accomplished early in a clinical program b y careful foreplanning utilizing available development program tools. Compassionate use programs provide an excellent framework for the collection of safety, tolerability, and pharmacokinetic data in pediatric populations. The conduct of formal pharmacokinetic studies in children may proceed in parallel with pediatric efficacy studies, ifappropriately designed and staged. Additional collection of meaningfir1 and predictive pharmacokinetic specimens may be accomplished in children without the need for repeated phlebotomy. Careful selection of target populations for phannacokinetic research in children may expedite rapid drug development of pediatric indications. Utilizing these techniques, a pediatric clinical development program may be prosecuted with minimal prior adult data and synchronous with the overall clinical development program. Key Words: Pleconaril; Rhinovirus; Enterovirus; Picornavims; Pediatrics
INTRODUCTION
disease due to rhinovirus is much more common in children and adolescents than in PICORNAVIRUS (ENTEROVIRUS AND adults (3). For these reasons, an antiviral rhinovirus) clinical diseases occur predomi- agent with unitary activity against picomavinantly in pediatric (infant, neonate, and ado- ruses will have its greatest use in pediatric lescent) populations. For example, Morens populations. A development program for an (1) reported a monoexponential decline in antipicomaviral agent which focuses its clinthe prevalence of enterovirus isolates re- ical objectives on adult populations will not ferred to the Centers for Disease Control and adequately address the predominant need for Prevention after infancy (Figure 1). Wilfert such an agent in children. observed a similar decrease in the incidence No approved antiviral therapies are availof enterovirus meningitis after the age of 10 able for the treatment of picomavirus infecyears in a Durham County, North Carolina tions. The mainstay of treatment continues survey (2) (Figure 2). In addition, respiratory to be directed toward symptomatic relief of the most prominent symptoms and signs of each clinical syndrome. The characterization of the three-dimensional structure of human Presented at the DIA “Seminar on Pediatric Drug De- picomaviruses by x-ray crystallography, howvelopment,” April 20-21, 1998, Arlington, Virginia. Reprint address: Jon M. Rogers, MD. 718 Peach ever, has been useful in guiding the rational Tree Drive, West Chester, PA 19380. E-mail: jrogers- design of drugs which inhibit picomavirus [email protected]. replication (4). One such molecular target 397
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