Abstract

Methylphenidate transdermal system uses DOT Matrix™ technology and, once applied to the skin, releases methylphenidate continuously. In the US, methylphenidate transdermal system is indicated for use in the treatment of attention-deficit hyperactivity disorder (ADHD). According to the results of a randomized, double-blind, multicentre, 7-week trial (core trial), methylphenidate transdermal system 10-30 mg was effective in adolescents aged 13-17 years with ADHD. The mean ADHD-Rating Scale-IV (ADHD-RS-IV) total score (primary endpoint) decreased to a significantly greater extent in adolescents receiving methylphenidate transdermal system than in those receiving placebo transdermal system. Following the core trial, adolescents could subsequently receive methylphenidate transdermal system in an extension study of ≈6 months duration. From the start of the core trial to the end of the extension study, methylphenidate transdermal system recipients demonstrated a significant reduction in the mean ADHD-RS-IV total score. Methylphenidate transdermal system was generally well tolerated in adolescents with ADHD. The vast majority of treatment-emergent adverse events were of mild to moderate severity in both the short-term core trial and the longer-term extension study.

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