Shire agrees to test its
ADHD drug in preschool children
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[June 13, 2014]
LONDON (Reuters) - Shire Plc SHP.L
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 drugmker 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
Drugs 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.
The company said it expects to launch the trials in the first half
ADHD patients have difficulty paying attention and may have poor
impulse control. Most drugs that treat the condition are potentially
addictive stimulants which, paradoxically, can help organize
thoughts and calm behavior.
But the drugs have been associated with growth suppression in
children and they can also cause hallucinations, mania and
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Very little research has been done on the effect of stimulants in
children. A search by researchers from the Mario Negri Institute for
Pharmacological Research in Milan, Italy, found just six studies
that monitored a total of 3,000 children for side effects for at
least 12 weeks.
Worldwide sales of Vyvanse grew 18 percent in the first quarter to
(Reporting by Paul Sandle; editing by Sarah Young)
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