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news.Shire, a biopharmaceutical company, has released findings on once-daily Intuniv (guanfacine) extended release tablets, the first selective alpha-2A agonist approved for the treatment of attention deficit hyperactivity disorder (ADHD), at a psychiatric meeting.
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Shire stated that the FDA approved Intuniv on September 2, 2009 as an ADHD treatment for children and adolescents ages 6 to 17, based on two pivotal monotherapy studies. The data presented were included as part of a supplemental new drug application (sNDA) submitted to the FDA on April 28, 2010 to seek approval for Intuniv as adjunctive treatment with long-acting oral stimulants for the treatment of ADHD in this patient population.
Shire said that the primary objective of this study was to evaluate the efficacy of Intuniv, dosed either in the morning or evening compared with placebo, when co-administered with stimulant medications used to treat ADHD in children and adolescents ages 6 to 17 with ADHD and suboptimal response to stimulant alone. The study met its primary end point, which was the change from baseline to end point in the ADHD Rating Scale-IV (ADHD RS-IV) total score.
The 9-week, randomised, double-blind, placebo-controlled, parallel-group, dose-optimised phase III study enrolled patients aged 6 to 17 years with a diagnosis of ADHD and suboptimal response to treatment with a long-acting stimulant.
Throughout the study, patients continued to take their same once-daily dose of a long-acting stimulant and were randomised to three treatment arms, Intuniv dosed in the morning, Intuniv dosed in the evening, or placebo. A total of 455 patients were evaluated for efficacy and safety. The study consisted of 5 weeks of dose optimisation and 3 weeks of dose maintenance. Intuniv was optimised up to 4mg per day.
Reportedly, the primary efficacy analysis was the change from baseline in ADHD-RS-IV total score at end point. ADHD-RS-IV is a standardised test for evaluating symptoms of ADHD and assessing response to treatment. At baseline, mean ADHD-RS-IV total scores were 37.6, 37.0, and 37.7 for the Intuniv am/stimulant, Intuniv pm/stimulant, and placebo/stimulant treatment groups, respectively.
At study end, mean ADHD-RS-IV total scores were 17.3, 16.1, and 21.7, respectively. Placebo-adjusted least squares (LS) mean change from baseline at end point for ADHD-RS-IV total score was a decrease of 4.5 for the Intuniv am/stimulant and a decrease of 5.3 for the Intuniv pm/stimulant.
Timothy Wilens, staff in the pediatric psychopharmacology unit at Massachusetts General Hospital and associate professor of psychiatry at Harvard Medical School, who led the study, said: “We hope that these new data from a large multisite controlled study evaluating the efficacy and safety of extended-release guanfacine co-administered with stimulants for the treatment of ADHD in children and adolescents is expected to be helpful to clinicians in the management of their patients with ADHD.”
Michael Yasick, senior vice president of ADHD business unit at Shire, said: “Shire is committed to ADHD and continues to develop a range of ADHD treatments. We are pleased with the results of this trial and are currently working with the FDA to secure an indication for use of Intuniv with stimulants in the treatment of ADHD.”