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Investigational Data Presented for INTUNIV™ (guanfacine) Extended-Release Tablets When Coadministered With Stimulants Showed ADHD Symptom Improvement in Overall, Morning and Evening Assessments
Date:10/28/2010

nt to patients and their families."

This study was supported by funding from Shire Development Inc.  Dr Timothy Wilens was a speaker for, received grant support from, and is a consultant for Shire.  

*Suboptimal response was defined as treatment with a stable dose of stimulant for at least four weeks with improvement, yet persistence of mild to moderate ADHD symptoms in the opinion of the investigator (defined as an ADHD-RS-IV total score of at least 24, Clinical Global Impressions-Severity of illness scale score of at least three).  Patients with no response to stimulants prior to study enrollment were excluded from participating in this study.

About INTUNIV

INTUNIV™ (guanfacine) Extended-Release Tablets is a nonstimulant approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17.  INTUNIV was approved by the US Food and Drug Administration (FDA) in September 2009 and comes in 4 doses—1 mg, 2 mg, 3 mg, and 4 mg.  INTUNIV should be taken once a day.

The active ingredient in INTUNIV is guanfacine.  INTUNIV is not a central nervous system (CNS) stimulant or a controlled substance.  It is not likely to cause dependence or be abused.

Additional information about INTUNIV and Full Prescribing Information are available at www.intunivpro.com.

Indication

INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 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 is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological,
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SOURCE Shire plc
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