Guanfacine has been approved by the Food and Drug Administration as an adjunct to stimulant medications for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6–17, the manufacturer announced in a statement.
The extended-release form of the drug, a selective alpha-2A adrenergic receptor agonist, previously had been approved as monotherapy for treating ADHD. The adjunctive therapy indication was based on a 9-week study of children and adolescents, according to the prescribing information for guanfacine, marketed as Intuniv by Shire PLC. The 9-week study included 455 patients with ADHD who had a suboptimal response to stimulant treatment.
Patients were randomized to receive a dose of guanfacine or placebo in the morning or evening or placebo in combination with the stimulant they had been receiving, with the dose of guanfacine starting at 1 mg titrated weekly over a 5-week period to a maximum of 4 mg/day, based on tolerability and clinical response.
At the end of 9 weeks, the mean reductions in total scores on the ADHD rating scale (ADHD-RS-IV) were significantly greater among those who received the combination than among those who continued on the psycho-stimulant alone.
The prescribing information states that it is indicated “as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome.”