May 26 2010
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. The data, presented in an oral session at a national scientific meeting of psychiatrists in New Orleans, LA, demonstrated that treatment with Vyvanse (30, 50, and 70 mg/d) significantly improved ADHD symptoms compared to placebo in adolescents with ADHD.
Vyvanse is currently indicated for the treatment of ADHD in children aged 6 to 12 years and in adults. Recently, Shire submitted a supplemental New Drug Application (sNDA) for use of Vyvanse in the treatment of adolescents aged 13 to 17 years with ADHD.
ADHD is one of the most common psychiatric disorders in children and adolescents. Sixty to 85 percent of children with ADHD may continue to meet criteria for the disorder during their teenage years. In the United States, it is estimated that approximately 9.7 percent of adolescents aged 13 to 17 years have been diagnosed with ADHD at some point in their lives based on results from the 2003 National Survey of Children's Health (NSCH), a telephone survey of households with at least one child aged 17 years or younger.(+)
"In this study, Vyvanse improved ADHD symptoms of inattention, hyperactivity and impulsivity in adolescents compared to placebo," said Ann C. Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas, Nevada and lead investigator for this study. "These results are important as we look for additional ways to effectively manage ADHD symptoms in adolescent patients."
As with other stimulant medications, Vyvanse is classified as a controlled substance (CII) because of its potential for abuse.
SOURCE Shire plc
COMO study focuses on the physical and mental health of children and adolescents in Germany