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Study Data Show INTUNIV™ (guanfacine) Extended Release Tablets Co-administered With Stimulants Provided ADHD Symptom Improvement in Children and Adolescents
Date:5/21/2010

ients with ADHD experience a suboptimal response to stimulant treatment for their ADHD.  Finding the right treatment while managing medication side effects may be complicated," said Timothy Wilens, M.D., staff in the pediatric psychopharmacology unit at Massachusetts General Hospital and associate professor of psychiatry at Harvard Medical School, who led the study.  "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 will be helpful to clinicians in the management of their patients with ADHD."

The US Food and Drug Administration (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.  These data presented today 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.  

In the pivotal trials, INTUNIV alone provided significant efficacy across a range of ADHD symptoms that can be disruptive, such as inattentiveness/being easily distracted, impulsivity/interrupting others, hyperactiv
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SOURCE Shire plc
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