A study published journal Child and Adolescent Psychiatry and Mental Health found once-daily Vyvanse® (lisdexamfetamine dimesylate) CII reduced the symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12.
The drug showed effectiveness from the first time point measured (1.5 hours) up to the last time point assessed (13 hours) after administering the drug. In this pediatric analog classroom study, treatment with Vyvanse was associated with significant improvement in behavior and attention
"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 demonstration of significant ADHD symptom improvement in children aged 6 to 12. Vyvanse is now one of the first oral ADHD stimulant treatments to have efficacy at 13 hours after administration for pediatric patients.
"Shire [pharmaceutical company] 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."
The study was a randomized, double-blind, placebo-controlled, analog classroom study that assessed the efficacy and safety of Vyvanse in 129 children 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 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. Other objectives included understanding the time for which VYVANSE was effective versus placebo, as measured by the SKAMP-D scale; also assessed was time of onset of Vyvanse compared with placebo according to 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 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).
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 liability.
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.
Vyvanse is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to 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