FDA has cleared Shire’s Daytrana® transdermal patch for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13-17 years. The methylphenidate patch system is already cleared in the U.S. for the treatment of children aged 6-12 years.
Daytrana is indicated for use as part of a total treatment program for ADHD that can include psychological, educational, and social measures.
Approval of Daytrana for the new age group is based on data from a Phase IIIb trial in 217 adolescents diagnosed with ADHD. Shire said the results showed use of the patch treatment led to significant reductions in the ADHD Rating Scale-IV total score from baseline compared with treatment using placebo.