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Investigational Data Presented for INTUNIV™ (guanfacine) Extended-Release Tablets When Coadministered With Stimulants Showed ADHD Symptom Improvement in Overall, Morning and Evening Assessments
Date:10/28/2010

treatment combined with stimulants in this same patient population.  The application is currently under review.  The target FDA action date is February 28, 2011.

In This Investigational Study, Coadministration of INTUNIV With a Stimulant Showed Significant ADHD Symptom Improvement Over Stimulant Alone When Dosed Either in the Morning or Evening

This multicenter, double-blind, randomized, placebo-controlled study took place over 9 weeks in 455 patients aged 6 to 17 years with ADHD who had suboptimal response* to treatment with a stimulant.

Throughout this dose-optimized study, patients continued to take their prescribed dose of a stimulant, with the addition of a morning or evening dose of INTUNIV (1 mg, 2 mg, 3 mg, or 4 mg) or placebo.  The primary efficacy measure for the study was the ADHD-RS-IV.  ADHD-RS-IV is a standardized tool for evaluating symptoms of ADHD and assessing response to treatment, in which clinicians can rate patients within a scoring range of 0 to 54, depending on the severity of symptoms.  At end point, a significantly greater percentage of patients in the morning and evening administration of INTUNIV and stimulant groups compared with those taking placebo with a stimulant met criteria for symptomatic remission (ADHD-RS-IV less than or equal to 18).  Data from the primary efficacy analysis of the study were previously presented at a national meeting of psychiatry in May 2010.  

Secondary efficacy measures were based on scores from the Conners' Global Index – Parent (CGI-P) morning and evening assessment, and the exploratory Before-School Functioning Questionnaire (BSFQ).  On a weekly basis, parents completed 2 assessments of the CGI-P, each composed of 10 questions.  The first assessment evaluated patient behaviors in the morning before school, and during the week before the study visit.  The second assessment evaluated patient behaviors in the evening,
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