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Shire Announces Positive Results of Studies With Guanfacine,Extended Release, An Investigational Nonstimulant Medication Filed,for the Treatment of ADHD in Children and Adolescents

ir randomized dose at week three. Then, participants maintained their assigned dose for three weeks, followed by three weeks of decreased dosing, so that all participants were taking 1 mg doses during week nine. Participants achieved overall significant mean reductions in ADHD-RS-IV total scores by study end, -19.6 points vs. -12.2 for placebo (P <.0001).

Safety data collected in trials 301 and 304 shows that participants using GXR had adverse events which were generally mild to moderate in severity, with most common side effects being sedative in nature. In trial 301, sedation- related treatment-emergent adverse events were among the most common but were usually transient and mild or moderate in severity. Treatment related adverse events greater than 10 percent included somnolence (32 percent), fatigue (18 percent), upper abdominal pain (14 percent) and sedation (13 percent). Mean decreases observed in heart rate, and systolic and diastolic blood pressure were modest. In trial 304, common treatment related adverse events greater than 5 percent included somnolence (27 percent), fatigue (9.4 percent) and nausea (5.1 percent). Small to modest changes in blood pressure, pulse rate, and ECG were observed with GXR but were not clinically meaningful.

Long-Term ADHD Symptom Improvement with GXR

Trial 303 was a long-term, open-label, safety follow-up study of 240 participants enrolled in trial 301. The objective was to assess the long-term safety of GXR 2 mg, 3 mg, and 4 mg doses in the treatment of ADHD for up to two years. In this study, investigators documented the ability of GXR to maintain clinically meaningful efficacy of ADHD symptoms for up to 24 months of treatment. Patients were optimized to a dose ranging between 2 mg to 4 mg. Doses could be adjusted by 1 mg per monthly visit.

In this trial, the most common treatment-emergent adverse events were somnolence (30.4 percent), headache (26.3 percent), fatigue (14.2 percent) and sedation (13
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