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| |  Transdermal Methylphenidate Appears Safe, Effective for Adolescents With ADHD: Presented at APA By Roberta Friedman, PhD SAN FRANCISCO -- May 21, 2009 -- Methylphenidate transdermal system (MTS) appears safe and effective in adolescents with attention deficit/hyperactivity disorder (ADHD), researchers reported here at the 162nd Annual Meeting of the American Psychiatric Association (APA). Treatment with the skin patch resulted in significantly improved ADHD behavioural symptoms compared with placebo, and most adverse events observed were mild to moderate in intensity. Robert Findling, MD, University Hospitals, Case Medical Center, Cleveland, Ohio, presented the results of the phase 3b trial at a poster presentation on May 18. Researchers randomised adolescents diagnosed with ADHD, aged 13 to 17 years, to MTS 10 to 30 mg or to a transdermal placebo, titrated over 5 weeks to an optimal dose of MTS, and then maintained on their optimal dose through a 2-week maintenance period. The patch is worn on the hip, alternating sides each day. Of the 217 teens were randomised to the 7-week treatment phase, 124 completed the study. Participants who did not achieve an acceptable dose within 5 weeks were withdrawn from the study. Response to medication was defined as lack of interfering side effects and at least a 25% decrease from baseline in the ADHD rating scale score. Scores of symptoms provided by the ADHD rating scale showed improvement from the time of study entry as compared with placebo patches. Mean scores from baseline were reduced by MTS (P < .0001), both in overall score and for the subscores. Advantages are that a patch can be removed if there is any problem, Dr. Findling said. The patch is intended for use for 9 hours during the day to deliver the medication, which will then taper down after the patch is removed. "Most people worry about sleep," but the patch use did not interfere. It allows teens to deal with their typical irregular sleep habits, Dr. Findling noted. He added the drug will remain in a person's system for 3 hours after the patch is taken off. A few participants in the trial developed severe skin reactions and 3 discontinued the trial for this reason. Most skin reactions to the patch were mild. Other adverse events included decreased appetite in about a quarter of the participants, and headache was reported by 12% in both groups. Funding for this study was provided by Shire Development Inc. [Presentation title: Efficacy and Safety of the Methylphenidate Transdermal System in Adolescents With ADHD. Abstract NR2-028]
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