Shire's Vyvanse Shows Efficacy in ADHD, According to Study
Posted on: Monday, 3 December 2007, 06:00 CST
Healthcare journal Biological Psychiatry has published the positive results of a study indicating that Shire's Vyvanse provided significant efficacy in children for up to 12 hours with attention deficit hyperactivity disorder.
Vyvanse also demonstrated low interpatient variability of measured pharmacokinetic parameters, as reported by the coefficient of variance.
This Phase II randomized, double-blind, placebo- and active-controlled crossover analog classroom study in children aged six to 12 examined the efficacy and safety of Vyvanse (30mg, 50mg or 70mg) and Adderall XR (mixed amphetamine salts extended-release: 10mg, 20mg or 30mg) compared with placebo.
Vyvanse demonstrated significant efficacy for treatment of attention deficit hyperactivity disorder (ADHD) for up to 12 hours post-dosing, based on the study's primary efficacy measure, SKAMP-D. Investigators observed a significant difference in patient behavior based upon the average of investigator ratings on the Swanson, Kotkin, Agler, M-Flynn and Pelham Rating Scale deportment (SKAMP-D) scores across eight classroom sessions held during a 12-hour treatment day between patients who received Vyvanse and patients who received Adderall XR, both compared to placebo.
In this study, pharmacokinetic parameters were also measured, which found that the coefficient of variance for time to maximum drug concentration for Vyvanse and Adderall XR were 15.33 and 52.77, respectively.
Source: Datamonitor
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