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New use cleared for Shire ADHD drug

The FDA has approved Shire's ADHD drug Intuniv for the new indication of adjunctive therapy to stimulants in children and adolescents aged six to 17

The US Food and Drug Administration has approved Shire's marketed attention deficit hyperactivity disorder drug Intuniv (guanfacine) for the new indication of adjunctive therapy to stimulants in children and adolescents aged six to 17. 

The approval makes the drug the only once-daily ADHD medication approved for administration as adjunctive therapy to stimulants. It is intended to offer a new option for patients who are having a suboptimal response to their existing stimulant therapy.

"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," said Michael Yasick, senior vice president of Shire's ADHD business unit.

The new approval is based on results from a nine-week placebo-controlled study of Intuniv in combination with each subject's current stimulant medication. Shire noted that the effectiveness of Intuniv for more than nine weeks has not been systematically evaluated. 

Intuniv, a nonstimulant selective alpha-2A agonist, is a long-acting version of the blood-pressure drug guanfacine, which is sold for the cardiovascular use by Promius Pharmaceuticals under the brandname Tenex as well as by generic drugmakers. 

Shire's original approval of the drug as a treatment for ADHD was issued by the FDA in 2009 and, like the new approval, covers patients aged six to 17. Intuniv brought in $166m in sales in its first full year on the market. 

The company's ADHD portfolio also includes the extended-release drug VyVanse (lisdexamfetamine dimesylate), which was approved in the US in 2007, and Adderall XR (dextroamphetamine and amphetamine), which was approved in 2001 and has patent protection until 2019 but will face generic competition sooner under the terms of settlements Shire made in response to patent challenges. 

1st March 2011

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