Shire’s Intuniv reduces ADHD symptoms in pivotal trial

The data showed that Intuniv demonstrated significant efficacy in reducing attention deficit hyperactivity disorder (ADHD) symptoms for patients taking the medication when compared to patients taking placebo at all measured time points up to 24 hours postdose.

The pooled analysis evaluated results from these patients on a weight adjusted mg/kg basis from two similarly designed, randomized, double-blind, forced-dose titration, multicenter Phase III trials. The primary efficacy measure for both studies was change in the ADHD Rating Scale (ADHD-RS-IV) total score from baseline to endpoint. All patient groups treated with Intuniv showed significantly greater improvement in ADHD-RS-IV total score from baseline to endpoint than the placebo group (P<.001). The ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment. The analysis also studied duration of effect using the Conners's Parent Rating Scale-Revised Short Form (CPRS-R), which is a comprehensive scale that used observer and self-report ratings to help assess ADHD and evaluate behavioral issues in children and adolescents. The data demonstrated significant improvement of ADHD symptoms based on total endpoint CPRS-R scores for all weight adjusted dose groups treated with Intuniv when compared to placebo for all time periods (at 12 hours, P=<.001; at 14 hours, P<.001; and at 24 hours, P=.003).