Positive study results for methylphenidate transdermal system

Philadelphia, US October 24, 2005 Shire announced at a major medical meeting in Toronto, Canada, that its investigational methylphenidate transdermal system (MTS) demonstrated statistically significant reductions in the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and was generally well tolerated in patients aged 6 to 12 in two clinical trials.

"Children with ADHD must cope with symptoms throughout the day and in a variety of environments, such as in the classroom, during after-school activities, or while at home," explained Sharon Wigal, Ph.D., associate clinical professor of Pediatrics at the University of California, Irvine Child Development Center. "While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide health care professionals and parents the first and only non-oral medication for children with the disorder."

The MTS patch was developed by Noven Pharmaceuticals, Inc. and combines the active ingredient of methylphenidate with Noven's patented DOT Matrix transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day. The transdermal system releases medication that passes through the skin and directly into the blood stream. The patch is water-resistant.

Data from phase II and phase III clinical trials presented Thursday and Friday in Toronto demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with MTS compared to children treated with placebo.

The phase II analog classroom study included 79 children with ADHD. The patch was worn for nine hours, and efficacy was assessed throughout the day for twelve hours. MTS demonstrated statistically significant improvement over placebo on the measures tested. Behavior, which was measured using the Swanson, Kotkin, Agler, M-Flynn,

Contact: Matthew Cabrey
Porter Novelli

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