FDA has cleared Shire’s Intuniv® (guanfacine) extended-release tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6–17 years, as part of a total treatment program. Approval in the U.S. is based on data from a nine-week trial evaluating the drug as combination therapy with a stimulant. The drug was approved in the U.S. as monotherapy for ADHD in September 2009, and Phase III development in the EU for the monotherapy indication is ongoing.
Intuniv is available in four doses, and Shire says the nonstimulant selective alpha-2A agonist is now the only once-daily ADHD therapy approved for adjunctive therapy in combination with stimulants. “This approval marks a significant development in our ADHD portfolio, one that may help to address symptoms that many children with ADHD may experience while on stimulant treatment,” comments Michael Yasick, senior vp of Shire’s ADHD business unit.
The nine-week placebo-controlled registrational study involved 455 patients who exhibited suboptimal responses to stimulant therapy for ADHD. Patients who were not responsive to stimulant therapy prior to the study were excluded. Eligible participants received a morning or evening dose of Intuniv 1 mg, 2 mg, 3 mg, or 4 mg, or placebo in combination with their usual stimulant therapy. The results showed that in comparison with placebo plus stimulant, treatment using Intuniv plus stimulant led to significant reductions in total ADHD-RS-IV scores from baseline. The ADHD-RS-IV scale includes both hyperactive/impulsive and inattentive subscales.