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TOPIC: Shire to Test ADHD Drug in 4- and 5-Year-Olds

Shire to Test ADHD Drug in 4- and 5-Year-Olds 15 Jun 2014 21:07 #339

Shire to Test ADHD Drug in 4- and 5-Year-Olds

Shire Plc. has agreed to a U.S. Food and Drug Administration request to study its stimulant Vyvanse in preschool children as concern rises over the diagnosis and treatment of attention deficit hyperactivity disorder, the drugmaker said on Thursday.

A report last year by the Centers for Disease Control and Prevention found that the number of children diagnosed with ADHD increased 41 percent from 2003 to 2011 and that 6.4 million children, or 11 percent of those aged 4 to 17, have been diagnosed with that condition.

Drug treatments include Ritalin, Adderall and Vyvanse. Only Adderall, which is also made by Shire, is approved to treat children under the age of 6. Yet children much younger are taking the drugs and the FDA wants additional information to ensure they are safe in this very young population.

Gwen Fisher, a spokeswoman for U.K.-based Shire, said the company is designing three clinical trials for children aged 4 to 5. One will examine how the body absorbs, breaks down and excretes drugs. Another will test for safety and efficacy. A third will test for safety over a longer period.


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