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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

asured were: inattentiveness/being easily distracted, running around or climbing excessively, arguing with adults, losing temper, and interrupting or intruding on others. Significant improvements 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).

Investigators also measured the efficacy of INTUNIV with the Clinical Global Impressions-Improvement (CGI-I) scale, a standard assessment used to rate the improvement of a patient's illness over the course of the study. The first pivotal trial found the percentage of subjects taking INTUNIV who were rated "much improved" or "very much improved" at end point ranged from approximately 50 to 56 percent across all doses versus approximately 26 percent for placebo (P<.05). Subjects taking INTUNIV in the second pivotal trial who rated "much improved" or "very much improved" at end point ranged from 54 to 56 percent across 1-mg (P=.0070), 3-mg (P=.0060), and 4-mg (P=.0040) doses versus 30 percent for placebo; the placebo-INTUNIV difference for the 2-mg dose was not significant (P=.1404).

Safety was also evaluated during these pivotal trials and safety data showed that adverse events reported by participants using INTUNIV were generally mild to moderate in severity, with the most common side effects being sedative in nature. Sedation-related, treatment-emergent adverse events were among the most common and were usually transient and mild to moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), fatigue (18 percent), upper abdominal pain (14 percent), and sedation (13 percent). Small to modest changes in blood pressure, pu
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