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GEN News Highlights : Jul 7, 2010

Shire’s Transdermal Patch for ADHD Gets FDA Thumbs Up for Use in Adolescents

Treatment shown to reduce rating scale in patients aged 13-17 years.

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.