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Shionogi ADHD drug wins US approval

Shionogi Inc. has won US Food and Drug Administration approval of extended-release Kapvay for attention deficit hyperactivity disorder in children

Shionogi Inc., the US unit of Japan's Shionogi & Co., has won US Food and Drug Administration (FDA) approval of extended-release Kapvay (clonidine hydrochloride), a non-stimulant treatment for attention deficit hyperactivity disorder (ADHD) in children and adolescents ages six to 17 years.

The oral drug, which can also be used as monotherapy, is "the first and only FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication," according to the company. The twice-daily, extended-release product is intended to stabilise the peaks and troughs in blood levels throughout the day.

The marketing application included data from two phase III studies showing that, at five weeks of treatment with Kapvay, children and adolescents with ADHD experienced statistically significant improvements in the core symptoms of inattention, hyperactivity and impulsivity.

"Maintenance efficacy has not been systemically evaluated and patients who are continued on longer-term treatment require periodic reassessment," the company noted.

4th October 2010

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