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INTUNIV demonstrated symptom reduction on oppositional subscale Conners' ADHD rating scale
Date:10/30/2009

ectively stimulate alpha-2A adrenoreceptors in the prefrontal cortex. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.

Once-daily INTUNIV is expected to be available in US pharmacies in November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg). INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

INTUNIV Demonstrated Significant Symptom Reduction in Patients Diagnosed with ADHD and the Presence of Oppositional Symptoms

This randomized, placebo-controlled, flexible-dose study was conducted in 214 patients ages 6 to 12 over a nine-week period. INTUNIV demonstrated significant ADHD symptom improvement in the primary and secondary measures as demonstrated on the Oppositional Subscale of the CPRS-R:L and the ADHD Rating Scale-IV (ADHD-RS-IV), respectively. The CPRS-R:L is a comprehensive scale that uses parent observer and self-report ratings to help assess ADHD symptoms and behaviors in children. At the study's end, patients taking INTUNIV showed significant symptom reduction as compared to patients taking placebo (-10.9 versus -6.8; effect size 0.59; P<.001) when assessed using the oppositional subscale of the CPRS-R:L. The ADHD-RS-IV scale assesses hyperactive, impulsive, and inattentive ADHD symptoms. ADHD-RS-IV mean change from baseline for INTUNIV versus placebo was -23.8 versus -11.5; effect size 0.92; P<.001. In this study, most treatment-emergent adverse events were mild to moderate. The most commonly reported treatment-emergent adverse events in patients taking INTUNIV (greater than or equal to 10 percent) were somnolence, headache, sedation, upper abdominal pain, and fatigue.

Dr Sallee added, "The data presented today provide additional support for the safety and efficacy profile of INTUNIV
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Contact: Matt Cabrey
mcabrey@shire.com
484-595-8248
Porter Novelli
Source:Eurekalert

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