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12-Month Study Demonstrated Tolerability and Efficacy of DAYTRANA,(methylphenidate transdermal system)

SAN DIEGO, May 23, 2007 /PRNewswire-FirstCall/ -- Shire plc announced that DAYTRANA(TM) (methylphenidate transdermal system), the first and only non-oral medication approved for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years, provided significant improvement in symptom control and tolerability, according to results of a 12-month open-label study presented at the American Psychiatric Association (APA) annual meeting in San Diego.

"We documented that children with ADHD experienced effective ADHD treatment with use of DAYTRANA for 12 months, sustaining the improvements in their ability to maintain focus and concentration," said investigator Oscar Bukstein, M.D., Associate Professor of Psychiatry, University of Pittsburgh School of Medicine. "More importantly, Daytrana maintained a favorable safety profile, meeting the study's primary endpoint, and demonstrating an incidence of adverse events that is consistent with previous trials and other stimulants in this class."

Shire's DAYTRANA is the first and only patch medication approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of ADHD in children aged 6 to 12 years. DAYTRANA is available in four dosage strengths - 10 mg, 15 mg, 20 mg and 30 mg - all designed for once-daily use. When worn for the recommended nine hours, efficacy has been demonstrated from the first time point measured (two hours) through the 12-hour time point. Because DAYTRANA is a patch, physicians may recommend that patients shorten the wear time if shorter duration of effect is desired or to help manage the potential for late-day side effects.

Bukstein added, "DAYTRANA's novel patch delivery system offers physicians and parents of children with ADHD a convenient, non-oral option to individualize ADHD treatment to meet their children's changing schedules."

This study was an open-label extension of four
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