Medication Monitor

Generic Name (Trade Name—Company)
March 1, 2011

Guanfacine extended-release tablets

Monotherapy for ADHD


Adjunctive therapy to stimulants for treatment of ADHD in children and adolescents 6–17 years of age

Intuniv was originally approved as monotherapy for treatment of ADHD in the same age group. Approval was based on data from a 9-week, multicenter, double-blind, placebo-controlled trial involving 455 children who had a suboptimal response to stimulant therapy. Combination therapy with guanfacine and a stimulant resulted in significant improvements on the ADHD Rating Scale–IV, which includes hyperactive/impulsive and inattentive subscales, compared with stimulant monotherapy. In addition, combination therapy was associated with mild to moderate adverse events similar to those observed with either treatment alone.