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Shionogi Announces FDA Approval of KAPVAY™ - The First and Only Therapy Approved for Use with Stimulant Medication for the Treatment of ADHD
Date:10/4/2010

VAY™, when added to a stimulant, addresses an unmet need, and improves ADHD symptoms beyond what is achieved by stimulants alone. This is a significant step forward for the treatment of ADHD to have an approved product for add-on therapy in our treatment armamentarium."

ADHD is a neurobehavioral disorder that occurs in childhood and may continue into adolescence and adulthood, which affects more than 4.5 million children ages 3-17 in the U.S. alone. Approximately 3-7 percent of U.S. school-aged children are believed to suffer from this disorder. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity/over-activity.

This approval is based on two Phase III studies, which demonstrated efficacy at 5-weeks that children and adolescents (6-17 years) with ADHD treated with KAPVAY™ experienced statistically significant improvements in core symptoms of ADHD – inattention, hyperactivity and impulsivity. The most common and drug related adverse reactions (incident at least 5% and twice the rate of placebo) included somnolence, fatigue, upper respiratory tract infection (cough, rhinitis, sneezing), irritability throat pain (sore throat), insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, drug mouth and ear pain.  Maintenance efficacy has not been systemically evaluated and patients who are continued on longer-term treatment require periodic reassessment.

About KAPVAY™

Administered orally, clonidine hydrochloride 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

KAPVAY™ should not be used in patients with known hypersensitivity to clonidine.

KAPVAY
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SOURCE Shionogi Inc.
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