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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

ity/running around excessively, arguing with adults, and losing temper.  INTUNIV is a non-scheduled medication and has no known potential for abuse or dependence.   INTUNIV is available in US pharmacies in four dosage strengths:  1 milligram (mg), 2 mg, 3 mg, and 4 mg.  

INTUNIV Co-Administered With a Stimulant Demonstrated Significant Symptom Improvement vs. Stimulant Alone

This 9-week, randomized, double-blind, placebo-controlled, parallel-group, dose-optimized phase III study enrolled patients aged 6 to 17 years with a diagnosis of ADHD and suboptimal response* to treatment with a long-acting stimulant.

Throughout the study, patients continued to take their same once-daily dose of a long-acting stimulant and were randomized to three treatment arms:  INTUNIV dosed in the morning, INTUNIV dosed in the evening, or placebo.  A total of 455 patients were evaluated for efficacy and safety.  The study consisted of 5 weeks of dose optimization and 3 weeks of dose maintenance.  INTUNIV was optimized up to 4 mg per day.  

The primary efficacy analysis was the change from baseline in ADHD-RS-IV total score at end point.  ADHD-RS-IV is a standardized test for evaluating symptoms of ADHD and assessing response to treatment.   At baseline, mean ADHD-RS-IV total scores were 37.6, 37.0, and 37.7 for the INTUNIV AM/stimulant, INTUNIV PM/stimulant, and placebo/stimulant treatment groups, respectively.  At study end, mean ADHD-RS-IV total scores were 17.3, 16.1, and 21.7, respectively.  Placebo-adjusted least squares (LS) mean change from baseline at end point for ADHD-RS-IV total score was a decrease of 4.5 (P=.002) for the INTUNIV AM/stimulant and a decrease of 5.3 (P<.001) for the INTUNIV PM/stimulant.

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SOURCE Shire plc
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