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Shire to Initiate Two Phase 4 Clinical Trials to Compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)
Date:3/6/2012

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  • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, decreased weight, vomiting, nausea, dizziness and dry mouth;
  • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
  • Adults: decreased appetite, insomnia, dry mouth, nausea, diarrhea, anxiety and anorexia.

  • Please click here for Full PrescribingInformation for Vyvanse (lisdexamfetamine dimesylate), including Boxed WARNING regarding Potential for Misuse, Abuse, Addiction, and Diversion.

    ABOUT ADHD

    Attention-Deficit/Hyperactivity Disorder is a neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity and is more frequent and severe than is typically observed in individuals at a comparable level of development.

    ADHD is one of the most common childhood psychiatric disorders. Although many people tend to think of ADHD as a childhood problem, 60% to 85% of children with ADHD may continue to meet the criteria for the disorder during their teenage years. Nearly 50% of children with ADHD may continue to meet the criteria for the disorder into adulthood, based on parent-report.  The disorder is estimated to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication. When this percentage is extrapolated to the full US population aged 18 and over, approximately 10 million adults are estimated to have ADHD.

    The specific etiology of ADHD is unknown, and there is no single diagnostic test for this disorder. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources, utilizing diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders,
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    SOURCE Shire plc
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    4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
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