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Published on 4 September 2009

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Shire announces FDA approval of Intuniv

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Shire plc, the global specialty biopharmaceuticalcompany, today announced that it has received approval from the US Foodand Drug Administration (FDA) for Intuniv (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)in children and adolescents aged 6 to 17 years.

Intuniv, a once-dailyformulation of guanfacine, is the first selective alpha-2A adrenergicreceptor agonist approved for the treatment of ADHD. Although themechanism of action is unknown, Intuniv is thought to directly engagereceptors found in the prefrontal cortex – an area of the brain thathas been linked in preclinical research to ADHD.

Stimulation of thepostsynaptic alpha-2A receptors is thought to strengthen workingmemory, reduce susceptibility to distraction, improve attentionregulation, improve behavioral inhibition, and enhance impulse control.

“Shire is proud to introduce Intuniv,providing clinicians, patients, and their families with a novel ADHDtreatment option,” said Mike Cola, President of Shire SpecialtyPharmaceuticals.

“This is a complex disorder in which patients maypresent with multiple symptoms and behaviors that can be disruptive.INTUNIV expands the Shire ADHD portfolio with a nonscheduledmedication, allowing clinicians to optimise their overall approachtoward managing ADHD and may help provide symptom control for childrenand teens with ADHD who often have difficulty responding appropriatelyto everyday situations and challenges.”

Once-daily Intunivis expected to be available in US pharmacies in November and will comein four dosage strengths (1mg, 2mg, 3mg, and 4mg). Intuniv will bemarketed in the United States by the existing Shire ADHD sales team ofnearly 600 representatives. Intuniv is not a controlled substance andhas no known potential for abuse or dependence.

“Everydaysituations and challenges may be difficult for children and adolescentswith ADHD as it is a disruptive disorder that includes symptoms andbehaviors such as being easily distracted, always on the go,interrupting others, arguing with adults, or temper outbursts,” saidFrank A. López, a neurodevelopmental pediatrician in privatepractice at Children’s Developmental Center in Winter Park, Florida.“In clinical trials, Intuniv, a selective alpha-2A receptor agonist,significantly reduced ADHD symptomsacross a full day as measured by parents at 6 PM, 8 PM, and 6 AM thenext morning. This is important because children with ADHD requiresymptom control at home, school, and during after school activities.”

Shire



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