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Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
Date:9/3/2009

of nearly 600 representatives. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

"Everyday situations and challenges may be difficult for children and adolescents with ADHD as it is a disruptive disorder that includes symptoms and behaviors such as being easily distracted, always on the go, interrupting others, arguing with adults, or temper outbursts," said Frank A. Lopez, MD, a neurodevelopmental pediatrician in private practice at Children's Developmental Center in Winter Park, Florida. "In clinical trials, INTUNIV, a selective alpha-2A receptor agonist, significantly reduced ADHD symptoms across a full day as measured by parents at 6 pm, 8 pm, and 6 am the next morning. This is important because children with ADHD require symptom control at home, school, and during after school activities."

The introduction of INTUNIV is consistent with the strategy of Shire to expand and diversify its ADHD portfolio, which now consists of four ADHD treatment options of scheduled and nonscheduled medicines in the United States and two ADHD medicines available outside the United States.

Additional information about INTUNIV and Full Prescribing Information are available at http://www.intuniv.com.

INTUNIV Demonstrated Significant Reduction in ADHD Symptoms

The efficacy of INTUNIV in the treatment of ADHD was established in two, similarly designed, placebo-controlled clinical trials in children and adolescents aged 6 to 17 years who met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV(R)) criteria for ADHD. Statistically significant improvements were reported by investigators, parents, and teachers.

The first pivotal trial was a phase III, double-blind, parallel-group trial, in which investigators randomized 345 children aged 6 to 17 years to eith
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