Daytrana for Children 6-12

Proven Symptom Management in Children Ages 6-12

Daytrana^® delivered significant symptom relief at all time points as compared with placebo.

SKAMP* Deportment (2-12 hours)

Mean change from predose in SKAMP^* Deportment Rating Scale (measured 2-12 hours)

Study 201: Randomized, double-blind, placebo-controlled analog classroom study of 93 subjects, aged 6 to 12 years, who met DSM-IV-TR^® criteria for a primary diagnosis of ADHD. The primary efficacy measure was SKAMP-D, measured at multiple time points during the two double-blind, crossover, laboratory classroom sessions at weeks 6 and 7.

^*Swanson, Kotkin, Agler, M-Flynn, and Pelham

^†P=.01 for difference between Daytrana and Placebo treatment. Adapted from McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. J Atten Disord. 2006:9:476-485.

• Efficacy of the Daytrana patch was established from the first point measured (2 hours) through 12 hours, with the recommended 9-hour wear time
• The Daytrana patch should be removed approximately 9 hours after it is applied
  • Efficacy was still demonstrated at 3 hours after removal of the patch
• The Daytrana patch delivered significant efficacy during the day
• In a separate analog classroom study, shorter wear time (4 and 6 hours) produced significant improvement in behavior vs placebo at all time points measured (2 hours to 6 or 8 hours, respectively) on the primary efficacy measure, SKAMP-D
• The most common adverse events associated with the Daytrana patch during dose optimization in this study were decreased appetite, anorexia, headache, insomnia, and upper abdominal pain. Although slight erythema at the patch site was common, the majority of patients reported no evidence or minimal evidence of irritation, and no discomfort or mild discomfort at application sites