The FDA has approved Kapvay (clonidine HCl extended-release tablets, from Shionogi) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6–17 years old. Kapvay is indicated for use as monotherapy or for use as add-on therapy to stimulant medication. This approval was based on two Phase 3 studies which demonstrated that children and adolescents (6–17 years) with ADHD treated with Kapvay experienced statistically significant improvements in core symptoms of ADHD (ie, inattention, hyperactivity and impulsivity).

Kapvay is a non-stimulant, centrally acting alpha2-adrenergic receptor agonist. The mechanism of action of alpha2 agonists in ADHD is unknown, but it is believed to involve the pre-frontal cortex (PFC) of the brain. Studies suggest that the PFC regulates attention and plays a critical role in impulse control, working memory and executive function.

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