Once-Daily VYVANSE(R) Significantly Improved ADHD Symptoms In One Of The Largest Controlled Stimulant Trials In Adults With ADHD

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that a study published in the September issue of the Journal of Clinical Psychiatry found once-daily VYVANSE significantly improved Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults within the first week of treatment. This study is the phase 3 pivotal trial submitted to the FDA and supported the approval in April 2008 of VYVANSE for adults with ADHD. VYVANSE was introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years and is now the fastest-growing ADHD prescription medication in the United States.



"This study adds to the growing body of research of ADHD in adults, and showed that VYVANSE provided effective symptom control for adults with this disorder," said Lenard A. Adler, M.D., lead researcher in this study and director of the Adult ADHD program at the NYU Langone Medical Center, associate professor of psychiatry, neurology and child and adolescent psychiatry at the New York University School of Medicine, as well as author of Scattered Minds: Help and Hope for Adults with ADHD (G. P. Putnam's Sons 2006). "It is important for people to realize that in adults, the core symptoms of ADHD - inattention, hyperactivity, and impulsivity - may present as inner restlessness, a lack of focus and organization, poor time management, or an inability to finish tasks, which can impact adults' daily lives. In this study, VYVANSE was shown, within the first week, to significantly improve ADHD symptoms of inattention, such as the ability to focus and organize, and hyperactivity and impulsivity, such as restlessness, and interrupting."



VYVANSE Significantly Improved ADHD Symptoms in Adults


In this randomized, double-blind, placebo-controlled, parallel-group, four-week study with dose escalations in 414 adults aged 18 to 55 years, adults with ADHD experienced significant improvements in ADHD symptoms within one week of treatment with once-daily VYVANSE.


Treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) was significantly more effective than placebo, with a mean reduction in ADHD Rating Scale (ADHD-RS-IV) scores (16.2 to 18.6 points; P