Vyvanse CII significantly improved ADHD symptoms for children 13 hours after administration

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that a study published online in the peer-reviewed journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse® (lisdexamfetamine dimesylate) CII significantly reduced the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 from the first time point measured (1.5 hours) up to the last time point assessed (13 hours) after administration. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention in children at each time point measured, with improvement at 13 hours after administration. "Pediatric patients may require ADHD symptom improvement both at school and after school," said Sharon Wigal, PhD, lead investigator of the study, clinical professor of pediatrics and director of clinical trials in the Child Development Center at the University of California, Irvine. "These published data are the first to have shown duration of effect of an oral ADHD stimulant in children aged 6 to 12 at 13 hours after administration. Physicians and caregivers who are seeking a long-acting medication that provides ADHD symptom improvement from morning through homework and family time may want to consider this Vyvanse study data."

On May 22, 2009, the US Food and Drug Administration (FDA) approved a change to the prescribing information for Vyvanse to include supplemental data that demonstrated significant ADHD symptom improvement in children aged 6 to 12 from the first time point measured (1.5 hours) up to 13 hours postdose. Vyvanse is now the first and only oral ADHD stimulant treatment to have efficacy at 13 hours after administration for pediatric patients included in its product labeling.

"Shire is proud to be at the forefront of ADHD research and treatment development and is committed to providing patients with effective ADHD medications, such as Vyvanse," said Liza Squires, MD, Research and Development Business Unit Leader for Shire. "These findings provided further support that Vyvanse can be an important treatment option for children who require duration of ADHD symptom improvement throughout the day."

Vyvanse Demonstrated Significant Symptom Improvement at 13 Hours After Administration

The study was a randomized, double-blind, placebo-controlled, analog classroom study that 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 included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of Vyvanse compared with placebo as measured by 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. Further, Vyvanse treatment was associated with significant efficacy as measured by both subjective (SKAMP-D and SKAMP-A) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day, and at all time points in between (2.5, 5.0, 7.5, 10.0, and 12.0 hours).

Safety was also evaluated during the study. The adverse event profile for Vyvanse was similar to other currently marketed stimulants. The most frequently reported adverse events (greater than or equal to 10 percent) in the dose-optimization phase for patients taking Vyvanse were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability.

Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 6 million Vyvanse prescriptions have been filled, bringing the current US market share to over 12 percent based on weekly branded prescription volume. Additionally, Shire has executed agreements with 10 of Shire's top 11 managed care organizations (MCOs) to cover Vyvanse in a preferred formulary position.

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.

Source: Porter Novelli