At the U.S. Psychiatric and Mental Health Congress, held in Las Vegas, Nev., Shire Pharmaceuticals reported 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. The data, from Phase II and Phase III clinical trials, demonstrated statistically significant improvements in the primary and secondary endpoints analyzed for children treated with MTS compared to children treated with placebo.
The MTS patch combines the active ingredient of methylphenidate with transdermal technology. The transdermal system releases medication that passes through the skin and directly into the blood stream. The patch is water-resistant.
The Phase II 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 improved with MTS throughout the day.
In the Phase III trial, with 270 participants, investigators found that MTS worn for nine hours reduced the children's overall symptoms of ADHD compared to a placebo. By the study's end, mean ADHD-RS scores declined by 56 percent from baseline for children treated with MTS, versus a decline of 24 percent for those treated with placebo.