DAYTRANA (methylphenidate Transdermal System) Significant Reduces ADHD Symptoms

Philadelphia, US - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced that its methylphenidate transdermal system (MTS), DAYTRANA TM demonstrated statistically significant reductions in the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) and was generally well tolerated in patients aged 6 to 12 years in four analyses of two clinical trials reported at a major medical meeting in Toronto.


"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 normal daily activities of a child such as swimming, exercising or bathing.


Because DAYTRANA is a patch, physicians can manage the duration of its effect and potential side effects by having the patient wear the patch for a shorter time period than the recommended nine hours on a given day. The patch is available in four dosage strengths - 10 mg, 15 mg, 20 mg and 30 mg - all designed for nine-hour wear times with 12-hour efficacy.


Phase II Analog Classroom Study


The phase II analog classroom study included 79 children with ADHD. DAYTRANA was assessed during a nine-hour wear time. The participants treated with DAYTRANA demonstrated statistically significant improvement based on the primary study measure, the standard Swanson, Kotkin, Agler, M-Flynn, and Pelham-Deportment (SKAMP-D) scale, in which higher ratings reflect greater impairment. Overall, participants using DAYTRANA significantly reduced their SKAMP-D scores to an average of 3.2 points compared to an average score of 8.0 points for those on placebo (P < .0001) from baseline.















Similarly, the DAYTRANA group significantly reduced their average total scores on two secondary measures from baseline, the SKAMP-attention subscale and SKAMP total subscale, to 6.2 and 9.4, respectively, compared to those on placebo, which had scores of 9.9 and 17.9 (P