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Investigational nonstimulant Guanfacine XR significantly improved child, adolescent ADHD symptoms

oints from baseline to endpoint (P <.001).

About Guanfacine 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.


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Contact: Marion E. Glick
212-601-8273
Porter Novelli
23-May-2007


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