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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

before bedtime.  The groups that received INTUNIV coadministered with a stimulant showed greater improvement compared with those taking placebo and a stimulant on the CGI-P at both morning and evening assessments.  Additionally, at end point, patients receiving INTUNIV coadministered with a stimulant showed greater improvement on the BSFQ compared with subjects who received placebo and a stimulant.  

In this investigational study, INTUNIV given in the morning or evening when coadministered with a stimulant resulted in significant improvement in ADHD symptoms overall and at morning and evening time points.

In this study, 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 (greater than or equal to 5 percent) were headache, upper respiratory tract infection, and irritability.  The majority of TEAEs were mild or moderate in severity.  No unique TEAEs were observed with INTUNIV given with a stimulant compared with those reported historically for either treatment alone.

Serious adverse events (SAEs) were reported in 3 patients taking INTUNIV and 1 sibling of a study participant (including one event of syncope).  All SAEs were considered unrelated to INTUNIV.

"We are currently awaiting FDA review of these data and our application for a change in the product labeling for INTUNIV to include coadministration with a stimulant for the treatment of ADHD," said Michael Yasick, Senior Vice President of Shire's ADHD Business Unit.  "Shire is pleased with the results of this trial and will continue to research and develop new treatments for ADHD as part of our commitme
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SOURCE Shire plc
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