A Phase 4, Open-Label, Single-Dose Pharmacokinetic Study of a Novel Methylphenidate Extended-Release Orally Disintegrating Tablet Formulation in Preschool-Aged Children

Abstract

In the United States, it is estimated that 1 in 3 children receive a diagnosis of ADHD during the preschool years (age <6 years), and ∼18 percent of patients with this diagnosis are treated with pharmacotherapy. Most of these prescriptions (∼91%) involve off-label use, reflecting the lack of approved medications for this age group. Furthermore, few studies provide information on prescribing ADHD medications in preschool-aged children. A methylphenidate extended-release orally disintegrating tablet (MPH XR-ODT) has been approved for children with ADHD ages ≥6 years.