FDA approves guanfacine ER tablets to treat ADHD in children, teens
Publish date: Mar 2, 2011
FDA approved the use of once-daily guanfacine (Intuniv, Shire) extended-release (ER) tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years as part of a total treatment program.
“ADHD can have such a negative impact on a youngster’s life,” Robert Findling, MD, told Drug Topics. Findling is director of child and adolescent psychiatry at University Hospitals Case Medical Center, Cleveland, and professor of psychiatry and pediatrics at Case Western Reserve University School of Medicine. “Intuniv’s approval for this new indication provides prescribers with a different way to offer help to youths who are still struggling with ADHD-related difficulties despite being treated with a stimulant.”
The approval is based on results from a 9-week placebo-controlled study of Intuniv given in combination with a stimulant to children and adolescents with ADHD. Intuniv is the only once-daily ADHD medication approved for administration as adjunctive therapy to stimulants.
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