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Shionogi Inc. Announces Commercial Availability of KAPVAY™ (clonidine hydrochloride) Extended-Release Tablets for the Treatment of ADHD
Date:1/10/2011

receiving KAPVAY™ discontinued from the pediatric monotherapy study due to adverse reactions.  In the pediatric adjunctive treatment to stimulants study, one patient out of 102 discontinued from KAPVAY™.

"There is a portion of children and adolescents who suffer from symptoms of ADHD who are not responding optimally to current therapies," said Rakesh Jain, MD, MPH, Assistant Clinical Professor, Department of Psychiatry, Texas Tech University School of Medicine – Permian Basin, Midland, Texas and Director of Psychiatric Drug Research for R/D Clinical Research at Lake Jackson, Texas, and one of the investigators in the clinical trials.  "The availability of an extended-release formulation of clonidine hydrochloride is an important addition to the current ADHD treatment landscape."

About KAPVAY™

KAPVAY™ (clonidine hydrochloride) extended-release is indicated for the treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications.  The efficacy of KAPVAY™ in the treatment of ADHD is based on two controlled trials (one monotherapy and one adjunctive to stimulant medication) in children and adolescents ages 6-17 who met DSM-IV criteria for ADHD hyperactive or combined hyperactive/inattentive subtypes.  KAPVAY™ is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome.  The effectiveness of KAPVAY™ for longer-term use (more than 5 weeks) has not been systemically evaluated in controlled trials.

Administered orally, KAPVAY™ exerts its pharmacological effects as a centrally acting alpha2-adrenoceptor agonist. The formulation in KAPVAY™ is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences.

Important Safety Information

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