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FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
Date:4/23/2008

points at endpoint.(1) The ADHD-RS-IV is a standardized test for assessing symptoms of ADHD and for assessing their response to treatment.(5,6) This scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the APA's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(R), a publication of the American Psychiatric Association.(7)

Investigators also measured the efficacy of VYVANSE with the Clinical Global Impressions-Improvement (CGI-I) scale and found that the percentage of subjects taking VYVANSE that rated improved ranged from 57 to 61 percent across all doses and was significantly greater than placebo.(1) The CGI-I scale is a standard assessment used to rate the severity of a patient's illness and improvement over time.(8)

The most commonly reported adverse events in this study were decreased appetite, difficulty falling asleep, and dry mouth.

About ADHD

ADHD is one of the most common psychiatric disorders in children and adolescents.(9) Approximately 7.8 percent of all school-aged 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).(10) The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders.(11) 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.(7) 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; th
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SOURCE Shire PLC
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