VYVANSE is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years. A Supplemental New Drug Application (sNDA) for VYVANSE for the treatment of ADHD in adults is currently under review by the FDA.
VYVANSE is a therapeutically inactive prodrug, 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 normal GI transit times.
Additional information about VYVANSE and Full Prescribing Information are available at http://www.vyvanse.com.
Approximately 7.8 percent of all school-age children, or about 4.4
million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at
some point in their lives, according to the U.S. Centers for Disease
Control and Prevention (CDC). ADHD is one of the most common psychiatric
disorders in children and adolescents. The disorder is also estimated to
affect 8.1 percent of adults, or approximately 9.2 million adults across
the U.S. based on a retrospective survey of adults aged 18 to 44, projected
to the full U.S. adult population. ADHD is a neurobiological disorder that
manifests as a persistent pattern of inattention and/or
hyperactivity-impulsivity that is more frequent and severe than is
typically observed in individuals at a comparable level of development. To
be properly diagnosed with ADHD, a child needs to demonstrate at least six
of nine symptoms of inattention; and/or at least six of nine symptoms of
hyperactivity/impulsivity; the onset of which appears before age 7 years;
that some impairment from the symptoms is present in two or more settings
(e.g., at school and home); that the symptoms continue for at least
|SOURCE Shire plc|
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