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New River says NRP104 reduces ADHD symptoms in children
New York, May 24 - New River Pharmaceuticals Inc. reported that a phase 3 trial of its NRP104 drug showed a reduction in the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 years.
The findings were presented Wednesday at the American Psychiatric Association annual meeting in Toronto.
In the study, 30 mg, 50 mg, and 70 mg QD doses of lisdexamfetamine dimesylate (NRP104) demonstrated significant improvements in ADHD symptoms compared with a placebo after four weeks of once-daily treatment, as measured by 230 children's scores on the ADHD Rating Scale (ADHD-RS). The scale is a standard test for diagnosing ADHD in children and adolescents and for assessing their response to treatment.
Average reductions in ADHD-RS scores were 50% (21.8 points), 54% (23.4 points) and 59% (26.7 points) for the 30 mg, 50 mg, and 70 mg dosage strengths, respectively, compared to baseline.
All three NRP104 doses produced significant decreases in the scores during the first week of treatment. Of the participants, 36% had previously received treatment for ADHD.
Each of the three dosage strengths (30 mg, 50 mg and 70 mg per day) demonstrated efficacy in the morning (around 10 a.m.), afternoon (around 2 p.m.) and evening (around 6 p.m.), compared to the placebo, as demonstrated by the Conners' ADHD Rating Scale - Parent (CPRS).
Most adverse events were mild to moderate and occurred in the first week. The most common adverse events were decreased appetite, insomnia, headache and upper abdominal pain. No unexpected adverse events in incidence or severity were observed in this study.
New River is a Radford, Va., specialty pharmaceutical company.
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