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Study Data Show INTUNIV™ (guanfacine) Extended Release Tablets Co-administered With Stimulants Provided ADHD Symptom Improvement in Children and Adolescents
Date:5/21/2010

tudy, no unique adverse events were observed with INTUNIV given with stimulant compared with those reported with either treatment alone.  The most commonly reported treatment emergent adverse events (TEAEs) among patients treated with INTUNIV and a stimulant (greater than or equal to 5 percent) were headache, somnolence, upper respiratory tract infection, fatigue, insomnia, upper abdominal pain, dizziness, decreased appetite, cough, irritability, and nausea.  The most commonly reported TEAEs among patients in the placebo/stimulant group were headache, upper respiratory tract infection, and irritability.  The majority of TEAEs were mild to moderate in severity.   The rate of discontinuation due to TEAEs was 2.7 percent in the INTUNIV AM/stimulant group, 3.9 percent in the INTUNIV PM/stimulant group, and 0.7 percent in the placebo/stimulant group.  There were three serious adverse events reported among study participants (including one report of syncope) and all were considered unrelated to study drug.  No deaths occurred during the study.

"Shire is committed to ADHD and continues to develop a range of ADHD treatments for health care providers and patients," said Michael Yasick, Senior Vice President of Shire's ADHD Business Unit.  "We are pleased with the results of this trial and are currently working with the FDA to secure an indication for use of INTUNIV with stimulants in the treatment of ADHD."  

This study was supported by funding from Shire Development Inc.  Dr Timothy Wilens was a speaker and 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 (defined as an ADHD-RS-IV total score of at least 24 an
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SOURCE Shire plc
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