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Shire Announces Positive Results of Studies With Guanfacine,Extended Release, An Investigational Nonstimulant Medication Filed,for the Treatment of ADHD in Children and Adolescents

nfacine Extended Release

Shire is seeking approval of GXR as monotherapy for the treatment of ADHD symptoms throughout the day in children aged 6 to 17 years, with dosage strengths of 1mg - 4 mg daily. The GXR NDA includes data from two placebo- controlled trials in children and adolescents ages 6 to 17 evaluating the compound's safety and efficacy in controlling ADHD symptoms evaluated on a once-weekly basis using the ADHD Rating Scale, which included both hyperactive/impulsive and inattentive subscales.

Guanfacine extended release is a once-daily formulation of a selective alpha-2A-adrenoceptor agonist. Unlike some other ADHD treatments, guanfacine extended release is not a central nervous system stimulant or a controlled substance and does not appear to have a mechanism for potential abuse or dependence.

It has been shown that guanfacine HCI binds selectively to the alpha 2A adrenergic cell receptors that are found throughout the part of the brain called the prefrontal cortex. The prefrontal cortex is an area of the brain associated with executive functioning, i.e., working memory, behavioral inhibition, regulation of attention, distractibility, impulsivity, and frustration tolerance.

About ADHD

Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the CDC. ADHD is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect approximately 9.8 million adults across the U.S. based on a retrospective survey of adults aged 18 to 34, projected to the full U.S. adult population. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child
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