Shionogi has received US Food and Drug Administration (FDA) approval for Kapvay (clonidine hydrochloride), an extended release oral formulation for the treatment of attention deficit hyperactivity disorder in children and adolescents aged six to 17 years old.

Kapvay, a centrally acting alpha2-adrenergic receptor, is the only FDA-approved formulation of clonidine hydrochloride for the treatment of ADHD.

In addition to being a monotherapy, it is also the only FDA-approved ADHD treatment that is indicated for use as an add-on therapy to stimulant medication.

The approval is based on two Phase II studies in which Kapvay showed efficacy at five weeks, where children and adolescents with ADHD who were treated experienced statistically significant improvements in core symptoms.