This nine-week, open-label, multicenter, dose-escalation study assessed the safety and effectiveness of coadministering INTUNIV with stimulant medications (methylphenidate or amphetamine). The enrolled patient population included 75 children and adolescents ages 6 to 17 diagnosed with ADHD whose ADHD symptoms were suboptimally controlled after at least one month of treatment with these stimulants. Investigators then started subjects at 1 mg/day of INTUNIV and increased the dose each week by 1 mg to the highest tolerated dose (1 mg/day, 2 mg/day, 3 mg/day, or 4 mg/day).( )Throughout the INTUNIV titration and maintenance phases of the study, subjects remained on the current dose of their stimulant medication.
The study met its primary objective which was to evaluate the safety of coadministration of INTUNIV (up to 4 mg/day) with stimulants. The study safety assessments included adverse events (AEs), vital signs, electrocardiogram (ECG) readings, physical examination, clinical laboratory tests, the Pediatric Daytime Sleepiness Scale (PDSS), and the Pittsburgh Side Effects Rating Scale (PSERS). AEs were generally mild to moderate. The most common treatment-emergent AEs seen with coadministration (>10.0 percent) were fatigue (34.7 percent), headache (33.3 percent), upper abdominal pain (32.0 percent), irritability (32.0 percent), somnolence (18.7 percent), and insomnia (16.0 percent). The most common treatment-emergent AEs that investigators deemed were possibly related or related to INTUNIV when given with either stimulant were upper abdominal pain (25.3 percent), fatigue (24.0 percent), irritability (22.7 percent), headache (20.0 percent), somnolence (18.7 percent), and insomnia (13.3 percent).( ) Similar proportions of both treatment groups (INTUNIV and amphetamine or INTUNIV and methylphenidate) experienced these treatment-emergent AEs. Blood pressure decreases, though frequent, were rarely rated by investigators as AEs: two subjects (2.7
|SOURCE Shire plc|
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