New Data Show Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Demonstrated Significant ADHD Symptom Reduction when Assessed Using the Oppositional Subscale of the Conners' ADHD Ra... (bo was -23.8 versus -11.5; effect size 0...)

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New Data Show Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Demonstrated Significant ADHD Symptom Reduction when Assessed Using the Oppositional Subscale of the Conners' ADHD Rating Scale

Date:10/29/2009

bo 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. The trial's flexible dose design gives clinicians a better look at how this medication may be used in clinical practice once it becomes available in November."

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

Important Safety Information

INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17. Efficacy was established in two controlled clinical trials (8 and 9 weeks in duration). The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.

INTUNIV should not be used in patients with a history of hypersensitivity to guanfacine or any of its inactive ingredients or by patients taking other products containing guanfacine.

Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, bradycardia, heart block, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Patients should be advised to avoid beco
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