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Phase III pivotal results presented of VYVANSE to treat ADHD in adults
May 09, 2008Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today presented the results of a phase III pivotal study in which VYVANSE demonstrated significant improvements in Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults and met all safety and efficacy endpoints.
"Adults with ADHD often find it challenging to focus and organize during the day. The disorder may impact many aspects of their lives from career to family and personal commitments," 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). "This study demonstrated that VYVANSE significantly improved ADHD symptoms in adults, including inattention, such as the ability to focus, organize and complete tasks, which are essential during an adult day, as well as hyperactivity, such as restlessness, and impulsivity."
This double-blind, placebo-controlled, four-week, forced-dose study in 414 adults aged 18 to 55 years showed that treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) provided a significant reduction in ADHD Rating Scale (ADHD-RS-IV) scores within one week that were observed throughout the full treatment period. At endpoint, VYVANSE demonstrated a significant improvement in ADHD symptoms, based on a 43 percent reduction in ADHD-RS scores. This is the largest placebo-controlled stimulant trial of ADHD in adults conducted to date.
Additional Study Findings 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 rated "much improved" or "very much improved" was approximately 60 percent across all doses and was significantly greater than placebo.
The most commonly reported adverse events in this study were generally mild to moderate in severity and included decreased appetite, insomnia and dry mouth.
On April 23, 2008, Shire received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. The FDA approved VYVANSE for the treatment of ADHD in children aged 6 to 12 years on February 23, 2007.
Porter Novelli
Additional Study Findings 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 rated "much improved" or "very much improved" was approximately 60 percent across all doses and was significantly greater than placebo.
The most commonly reported adverse events in this study were generally mild to moderate in severity and included decreased appetite, insomnia and dry mouth.
On April 23, 2008, Shire received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. The FDA approved VYVANSE for the treatment of ADHD in children aged 6 to 12 years on February 23, 2007.
Porter Novelli
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