"Children with ADHD and their caregivers must manage symptom control throughout the day in a variety of settings, such as the classroom, after-school activities, or home," explained clinical trials principal investigator Sharon Wigal, Ph.D., associate clinical professor of pediatrics at the University of California Irvine Child Development Center. "These studies document that a methylphenidate transdermal 'skin' patch formulation is an effective, once-daily ADHD treatment that can result in the improvement of multiple measures of behavior and classroom performance."
DAYTRANA was approved by the U.S. Food and Drug Administration (FDA) for once-daily use to treat Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years on April 6, 2006. DAYTRANA is the first and only non-oral medication for ADHD. Shire expects DAYTRANA to be available in pharmacies in mid 2006.
Data from phase II and phase III clinical trials presented Wednesday in Toronto demonstrated that DAYTRANA is a generally well-tolerated and effective treatment for ADHD in children as shown through improvements in the primary and secondary endpoints analyzed for children treated with DAYTRANA compared to children treated with placebo.
DAYTRANA was developed by Noven Pharmaceuticals, Inc., and combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day. The patch is designed to stay on during the norm
Contact: Matthew Cabrey, Shire