Shire announced at the US Psychiatric and Mental Health Congress in Las Vegas, Nevada, 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 who have ADHD must cope with symptoms throughout the day and in a number of environments, including in the classroom, during extra-curricular activities, or while at home," explained Frank Lopez, MD, developmental pediatrician at the Children's Developmental Center, Maitland, Florida. "While oral methylphenidate has long been a first-line treatment for patients with ADHD symptoms, if approved, this transdermal patch formulation would provide parents and health care professionals the first and only non-oral medication for children with ADHD."
The MTS patch was developed by Noven Pharmaceuticals, Inc. and combines the active ingredient of methylphenidate with transdermal technology. This transdermal deliveryNoven's patented DOT Matrix 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 this week in Las Vegas 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 measur