Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Clark Health Communications

Clark Health Communications (CHC) is an independent, award-winning health and medical communications agency. Our collaboration with experts and advocates enhances...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics