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news.Shire, a specialty biopharmaceutical company, has received the US Food and Drug Administration’s (FDA) approval to use the once-daily INTUNIV (guanfacine) Extended-Release Tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents ages 6 to 17.
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The approval is based on the satisfactory results obtained from a 9-week, multicenter, double-blind, randomized, placebo-controlled study of INTUNIV in combination with a stimulant in children and adolescents with ADHD.
INTUNIV is a selective alpha-2A agonist nonstimulant, and is the only once-daily ADHD medication approved for administration as adjunctive therapy to stimulants.
However, the effectiveness of INTUNIV has not been systematically evaluated for more than 9 weeks.
Lead investigator for the study and Case Western Reserve University School of Medicine professor of psychiatry & pediatrics Robert Findling said the once-daily dosing of INTUNIV in this study was effective when taken in the morning or the evening, which gave physicians flexibility while treating ADHD patients.
Shire senior vice president of ADHD business unit Michael Yasick said that the approval marks a significant development in the company’s ADHD portfolio.