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Adjunctive therapy for ADHD approved

The FDA has approved once-daily guanfacine as adjunctive therapy for the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6 to 17 years.

Guanfacine (Intuniv, Shire), which is a selective alpha-2A agonist, is the only approved adjunctive therapy to stimulants. It was initially approved as monotherapy 2 years ago.

During a 9-week, multicenter, double blind, randomized, placebo-controlled study, 455 patients who had a suboptimal response to stimulant treatment for ADHD received a morning or evening dose of 1 mg, 2 mg, 3 mg or 4 mg of the study drug or placebo combined with their prescribed dose of a stimulant.

Clinicians using the ADHD Rating Scale IV, which includes both hyperactive/impulsive and inattentive subscales, reported significant reductions in total scores from baseline at endpoint for patients receiving guanfacine and stimulant when the medication was dosed either in the morning or evening vs. placebo and stimulant.

Most adverse events were mild or moderate in severity and no unique events were observed with the study medication compared with those reported historically for either treatment alone. Three percent of patients receiving Intuniv plus stimulant discontinued from the study due to adverse events vs. 1% in the placebo group.

“In this study, the once-daily dosing was effective when taken in the morning or the evening, giving physicians flexibility when it comes to treating their patients with ADHD,” Robert Findling, MD, of University Hospitals Case Medical Center, and lead investigator for the study, said in a press release.

According to materials provided by Shire, the study medication’s effectiveness for more than 9 weeks has not been systematically evaluated, and physicians seeking to use it for longer should “periodically re-evaluate its long-term usefulness for the individual patient.”

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