Shire Presents Data For Vyvanse Phase 3 Study

Shire has reported findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors’ Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

The post hoc analysis showed that patients demonstrated an improvement in emotional lability composite CPRS-RS scores while taking Vyvanse as compared to placebo.

This post hoc analysis was based on a Phase 3, randomised, double-blind, placebo-controlled trial with forced-dose escalation of Vyvanse (30, 50, or 70mg/d) or placebo in 285 children aged 6 to 12 years with ADHD. The primary end point of the study was the ADHD-RS IV, and secondary end points included CPRS-RS and safety.

The CPRS-RS scale in its entirety contains 27 items to evaluate children’s behaviors based on parents’ responses. Each of the CPRS-RS 27 items is scored from zero as ‘Not At All True/Never, Seldom’ up to three as ‘Very Much True/Very Often, Very Frequent.’

The study illustrates that parents completed the CPRS at 10 am, 2 pm, and 6 pm at study start and on the day before their children made the weekly study visits. In the post hoc analysis, the children’s emotional lability score was determined based on the sum of their average scores from three items on the CPRS-RS like angry/resentful, loses temper, and irritable.

Patients were then grouped into those with and without prominent emotional lability at study start (scores greater than three versus scores of three or less) so that each group could be evaluated separately.

Overall, the children’s average emotional lability scores significantly improved with Vyvanse treatment compared with placebo across the day (10 am, 2 pm, and 6 pm) from study start to end.

As expected, treatment with Vyvanse, compared to placebo, did not result in significant improvements in emotional lability scores from study start to end in those without prominent emotional lability prior to treatment. However, treatment with Vyvanse, compared to placebo, yielded significant improvements in the emotional lability scores of those children with prominent emotional lability.