The US Food and Drug Administration (FDA) has approved Daytrana for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.
Daytrana is a transdermal patch that delivers methylphenidate. Its effects are expected to continue for several hours after the patch is removed.
A Phase IIIb study of the patch involving 217 adolescents with ADHD demonstrated significant reduction in ADHD-RS-IV total score from baseline to endpoint compared with a placebo.
It also reported nausea, decreased appetite, weight loss, insomnia, dizziness and anorexia as some of the most common adverse reactions.
Daytrana is globally licensed to Ireland-based biopharmaceutical company Shire by the US-based Noven Pharmaceuticals.
The drug has already received an FDA approval for ADHD treatment in children aged six to 12 years.