Once-daily INTUNIV (guanfacine) extended release tablets now available in US ...(uated participants' signs and symptoms o...),Health

Date:11/9/2009

uated 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 symptoms and behaviors in children and adolescents. Among some of the symptoms measured were: inattentiveness/being easily distracted, running around or climbing excessively, arguing with adults, losing temper, and interrupting or intruding on others. Significant improvements in mean day total scores were seen on both scales: based on the CPRS-R, parents reported significant improvement across a full day (as measured at 6 PM, 8 PM, and 6 AM the next morning); based on the CTRS-R, which was used only in the first pivotal trial, teachers reported significant improvement throughout the school day (as measured at 10 AM and 2 PM).

Safety was also
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Contact: Matt Cabrey mcabrey@shire.com 484-595-8248 Porter Novelli Source:Eurekalert

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