FDA Approves 30-Minute Onset Label for ADHD Med

Stimulant medication may be useful for controlling children's symptoms in the mornings

The FDA has approved a new labeling, 30-minute onset of action, for Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of attention deficit hyperactivity disorder (ADHD), bringing potential benefits for children and their families during the morning period when they are preparing for school.

The new labeling is based on clinical data from a study from Baylor College of Medicine. In the study of 86 children with ADHD between the ages of six and 12, Focalin XR (from Novartis Phamaceuticals) provided significant improvements at 30 minutes post-dose compared to placebo in measures of attention, deportment, and academic productivity.

The extended-release medication also helps patients manage symptoms for up to 12 hours. The most common side events were dyspepsia, decreased appetite, headache and anxiety in pediatric studies; and dry mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult studies.

Read more about the medication.