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Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
Date:9/3/2009

er a placebo or a fixed 2-mg, 3-mg, or 4-mg dose of INTUNIV given once daily during an eight-week period. The second pivotal trial was a phase III, double-blind, parallel-group trial, in which investigators randomized 324 children aged 6 to 17 years to either a placebo or a fixed 1-mg, 2-mg, 3-mg, or 4-mg dose of INTUNIV given once daily during a nine-week period, with the 1 mg assigned only to patients weighing less than 50 kg (110 lbs).

In both trials, doses were increased in increments of 1 mg per week, and investigators evaluated participants' signs and symptoms of ADHD on a once-weekly basis using the clinician administered and scored ADHD Rating Scale-IV (ADHD-RS-IV), a scale frequently used in ADHD clinical trials that assesses hyperactive, impulsive, and inattentive symptoms. The primary outcome was the change in total ADHD-RS-IV scores from baseline to end point in both studies.

Both trials demonstrated statistically significant improvements in ADHD-RS-IV scores in patients taking INTUNIV beginning one to two weeks after patients began receiving once-daily doses of INTUNIV. In the first pivotal trial, the mean reduction in ADHD-RS-IV total scores at end point were -16.7 for INTUNIV compared to -8.9 for placebo (P<.0001), the mean reduction in ADHD-RS-IV total scores in the second pivotal trial were -19.6 for INTUNIV and -12.2 for placebo (P=.0040). Placebo-adjusted LS mean changes from baseline were statistically significant for all INTUNIV doses in the randomized treatment groups in both studies.

Additional secondary efficacy outcome measures included the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R) and the Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R). CPRS-R and CTRS-R are comprehensive scales that use parent and teacher observer and self-report ratings to help assess ADHD and evaluate behavioral issues in children and adolescents. Among some of the symptoms me
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