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Shionogi Inc. Announces Publication of Data in Pediatrics Demonstrating Efficacy of KAPVAY™ (clonidine hydrochloride) Extended-Release Tablets as Add-On Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
Date:5/9/2011

FLORHAM PARK, N.J., May 9, 2011 /PRNewswire/ -- Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced the publication in Pediatrics of data demonstrating the efficacy of non-stimulant KAPVAY™ (clonidine hydrochloride) extended-release tablets when combined with stimulant medications for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents (6-17 years). This study, the first to evaluate KAPVAY in combination with stimulants in ADHD patients with inadequate response to stimulants, showed a significantly greater (40%) improvement in symptoms associated with the condition. The data from the Phase III clinical trial appear in an article in the May 9, 2011 online edition of Pediatrics, the medical journal of the American Academy of Pediatrics, in advance of the print edition.

"Nearly one third of the 4.5 million children with ADHD in the U.S. do not achieve optimal response from stimulant monotherapy, therefore a need exists for additional treatment options for this population," said Matthew Brams, MD, Clinical Assistant Professor, Department of Psychiatry, Baylor College of Medicine, Houston, TX, investigator in the clinical trial and co-author of the Pediatrics article. "These study findings suggest that the extended-release version of clonidine hydrochloride, when prescribed as an add-on to stimulants, is useful in reducing ADHD symptoms in children and adolescents ages 6 to 17 with inadequate response to stimulants."

The eight-week Phase III randomized, double-blind, placebo-controlled trial of 198 children and adolescents (6-17 years) with ADHD demonstrated significant efficacy at Week 5 (primary endpoint) in patients treated with KAPVAY plus stimulant (n=102) compared to a placebo plus stimulant (n=96). Signs and symptoms of ADHD were evaluated using the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHDRS-IV) total scor
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