CHICAGO October 29, 2008 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced results from a 13-hour analog classroom study in school-aged children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). In this study, researchers found that VYVANSE controlled ADHD symptoms from the first time point measured (1.5 hours) through the last time point assessed (13 hours) post-dose. Findings from this analog classroom study were presented today at a national psychiatric meeting in Chicago.
"The study presented today is the first published data demonstrating improvements in attention and behavior with an oral ADHD stimulant treatment for up to 13 hours post-dose," said Ann C. Childress, MD, study investigator, president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas, and volunteer assistant professor of psychiatry at the University of Nevada School of Medicine in Las Vegas. "In this study, once-daily VYVANSE significantly improved attention and behavior at 1.5 hours after a morning dose of the medication and continued to do so for each time point measured throughout the 13-hour treatment day. These findings are significant because children with ADHD require symptom control that lasts throughout the school day as well as after-school hours."
This study confirms the results of a previous clinical trial in which VYVANSE demonstrated ADHD symptom control throughout a 12-hour treatment day. The adverse events in the 12-hour study for patients taking Vyvanse during the double-blind treatment period that were greater than or equal to 2 percent were insomnia, decreased appetite, and anorexia.
"This is encouraging news for physicians and patients seeking a long-acting ADHD treatment option as this study demonstrated symptom control during a 13-hour treatment day," said Mike Cola, President of Shire's Specialty Pharmaceuticals business. "This VYVANSE study further supports Shire's commitment to research efforts that address the need for ADHD symptom control throughout the day, and into the evening."
About the 13-Hour Analog Classroom Study
This randomized, double-blind, placebo-controlled, analog study assessed the efficacy and safety of VYVANSE in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The second group received placebo the first week and their optimal dose of VYVANSE the second week.
The primary objective of this study was to assess the time of onset of VYVANSE compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives were to assess the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D, SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales.
In the study, VYVANSE demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. VYVANSE treatment was associated with significant improvement in behavior and attention as measured by both subjective (SKAMP-D) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day.
When measured using the PERMP scales, VYVANSE demonstrated significant improvement in math problems attempted and answered correctly with improvement for up to 13 hours post-dose.
Safety was also evaluated during the study and VYVANSE was generally well tolerated. The most frequently reported adverse events for patients taking VYVANSE were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability.
VYVANSE, which was introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years, was approved in April 2008 to treat ADHD in adults. VYVANSE is now available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 3 million VYVANSE prescriptions have been filled.
VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times.
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