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Oct 4, 2010

FDA Clears Shionogi’s Nonstimulant ADHD Therapy

  • Shionogi gained approval of the nonstimulant medication Kapvay™ (clonidine hydrochloride), an extended-release oral formulation for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents ages 6–17 years. Kapvay is reportedly the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD and is the first FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication. The drug can also be used as monotherapy when treating ADHD.

    An oral, nonstimulant, twice-daily therapy, Kapvay is a centrally acting alpha2-adrenergic receptor agonist. While the mechanism of action of alpha2 agonists in ADHD is not known, it is believed to involve the prefrontal 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.

    “The extended-release formulation of Kapvay minimizes the peaks and troughs in blood levels, thereby decreasing overactivation of the alpha receptors in the brain and periphery,” explains Donald C. Manning, M.D., Ph.D., CMO of Shionogi.

    FDA sanction of Kapvay is based on two Phase III studies, which demonstrated efficacy at five weeks. 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 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.

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