Kapvay (clonidine hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved October 2010

Specific Treatments:

attention deficit hyperactivity disorder

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General Information

Kapvay is an extended release formulation of clonidine hydrochloride, a centrally acting alpha2-adrenergic agonist. However, the mechanism of action of clonidine in ADHD is not known.

Kapvay is specifically indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

Kapvay is supplied as a tablet for oral administration. Dosing should be initiated with one 0.1 mg tablet at bedtime, and the daily dosage should be adjusted in increments of 0.1 mg/day at weekly intervals until the desired response is achieved. Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime.

Clinical Results

FDA Approval
The FDA approval of Kapvay was based on two clinical studies: one monotherapy and one adjunctive therapy.
Monotherapy Study
This 8-week randomized, double-blind, placebo-controlled, fixed dose study enrolled 236 children and adolescents aged 6 to 17 years old. The subjects were assigned to one of the following three treatment groups: Kapvay 0.2 mg/day or 0.4 mg/day or placebo. Dosing for the Kapvay groups started at 0.1 mg/day and was titrated in increments of 0.1 mg/week to their respective dose (as divided doses). Patients were maintained at their dose for a minimum of 2 weeks before being gradually tapered down to 0.1 mg/day at the last week of treatment. At both doses, improvements in ADHD symptoms were statistically significantly superior in Kapvay-treated patients compared with placebo-treated patients at the end of 5 weeks as measured by the ADHDRS-IV total score.
Adjunctive Therapy
This 8-week randomized, double-blind, placebo-controlled, flexible dose study enrolled 198 children and adolescents aged 6 to 17 years old. The subjects had been treated with a psychostimulant (methylphenidate or amphetamine) for four weeks with inadequate response. They were randomly assigned to one of two treatment groups: Kapvay adjunct to a psychostimulant or psychostimulant alone. The Kapvay dose was initiated at 0.1 mg/day and doses were titrated in increments of 0.1 mg/week up to 0.4 mg/day, as divided doses, over a 3-week period based on tolerability and clinical response. The dose was maintained for a minimum of 2 weeks before being gradually tapered to 0.1 mg/day at the last week of treatment. ADHD symptoms were statistically significantly improved in Kapvay plus stimulant group compared with the stimulant alone group at the end of 5 weeks, as measured by the ADHDRS-IV total score.

Side Effects

Adverse effects associated with the use of Kapvay may include, but are not limited to, the following:

  • somnolence
  • fatigue
  • upper respiratory tract infection
  • irritability
  • throat pain
  • insomnia
  • nightmares
  • emotional disorder
  • constipation
  • nasal congestion
  • increased body temperature
  • dry mouth
  • ear pain

Mechanism of Action

Kapvay is an extended release formulation of clonidine hydrochloride, a centrally acting alpha2-adrenergic agonist. However, the mechanism of action of clonidine in ADHD is not known.

Additional Information

For additional information regarding Kapvay or attention deficit hyperactivity disorder, please visit the Kapvay web page.