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Shire reports analysis examining emotional lability in children with ADHD taking Vyvanse
Date:11/13/2009

t hoc analysis, the children's emotional lability score was determined based on the sum of their average scores from three items on the CPRS-RS: angry/resentful, loses temper, and irritable. Patients were then grouped into those with and without prominent emotional lability at study start (scores greater than three versus scores of three or less) so that each group could be evaluated separately.

Overall, the children's average emotional lability scores significantly improved with Vyvanse treatment compared with placebo across the day (10 AM, 2 PM, and 6 PM) from study start to end (all P≤.0004).

As expected, treatment with Vyvanse, compared to placebo, did not result in significant improvements in emotional lability scores from study start to end in those without prominent emotional lability prior to treatment. However, treatment with Vyvanse, compared to placebo, yielded significant improvements in the emotional lability scores of those children with prominent emotional lability (P<.0001).

The most common treatment-emergent adverse events reported in this study for patients taking Vyvanse were decreased appetite, insomnia, upper abdominal pain, headache, irritability, vomiting, weight decrease, nausea, dizziness, and dry mouth.

Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Vyvanse is a therapeutically inactive prodrug stimulant, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times.


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

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