Transdermal delivery of methylphenidate passes a test of efficacy in ADHD

June 8, 2006

New research reported at the annual meeting of the American Psychiatric Association in Toronto in May shows that Shire Pharmaceutical Group's methylphenidate transdermal system (Daytrana) appears a safe and well-tolerated alternative to OROS methylphenidate, and is equally efficacious.

New research reported at the annual meeting of the American Psychiatric Association in Toronto in May shows that Shire Pharmaceutical Group's methylphenidate transdermal system (Daytrana) appears a safe and well-tolerated alternative to OROS methylphenidate, and is equally efficacious.

The double-blind, double-group, dose-optimization study (five weeks of optimization followed by two weeks of maintenance) included 270 children between 6 and 12 years old who were given a diagnosis of attention-deficit hyperactivity disorder. Participants were randomized into three treatment groups: Daytrana plus placebo capsule; OROS methylphenidate (overencapsulated) plus placebo patch; and placebo capsule plus placebo patch.

The ADHD-Rating Scale-IV (ADHD-RS-IV) was administered at each visit. Efficacy was measured by changed in the ADHD-RS-IV from baseline. Behavior was assessed on the ADHD-RS-IV subscales for inattentiveness and hyperactivity/impulsivity.

At the end of the study, a greater than 30% reduction in the ADHD-RS-IV score was observed in 77.6% of children who received Daytrana; in 66.3% of the children who received OROS methylphenidate; and in 28.7% of those who received placebo.

Decreases from baseline on the hyperactivity/impulsivity subscale were 11.8, 10.6, and 5.2 for, respectively, Daytrana, OROS methylphenidate and placebo groups. Decreases from baseline on the inattentiveness subscale for the three groups were, respectively, 12.4, 11, and 5.2.