OMG-FDA Panel Backs Patch To Treat ADHD in Children

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FDA Panel Backs Patch

To Treat ADHD in Children

 

By JENNIFER CORBETT DOOREN

DOW JONES NEWSWIRES

December 2, 2005 4:23 p.m.

 

WASHINGTON -- A Food and Drug Administration panel backed a proposed skin

patch Friday to treat attention deficit hyperactivity disorder, or ADHD, in

children.

 

But the panel also said the product, by Shire Pharmaceuticals Group PLC, based

in the U.K., and Noven Pharmaceuticals Inc., Miami, should contain a strong

recommendation to physicians that they try oral drugs first until more

information is known about skin reactions to the patch.

 

One clinical study showed that about 20% of patients experienced skin

irritation from the patch, which would be attached near the hip. The FDA's panel

of outside medical experts said more information is needed to instruct patients

and their caregivers about when to tell whether a skin reaction is minor or

whether it suggests a serious allergic reaction to the medication.

 

The patch would be used in place of drugs normally taken orally to treat the

neurological disorder in children ages 6 to 12. Shire also makes the popular

ADHD drug Adderall.

 

The FDA normally follows its panels' advice but doesn't have to. The FDA is

set to make a decision on the product by the end of the month.

 

The panel's decision came after a surprising reversal by an FDA medical

reviewer who had recommended that the agency reject the patch on safety

concerns. (See related documents1.) The reviewer, Robert Levin, said that, since

his opinion was written last month, he had time to obtain additional data on the

patch, which mitigated some of his concerns that the drug caused weight loss and

insomnia. Dr. Levin's negative review was posted Thursday to the FDA's Web site.

Dr. Levin then offered the panel a more upbeat assessment on Friday.

 

" In the big picture, there were no deaths and no serious adverse events, " Dr.

Levin said. " I think it's a reasonably safe treatment. " He noted that the side

effects seen with the patch were similar to those seen in some oral ADHD drugs.

Dr. Levin said he wasn't pressured by the companies or his FDA bosses to change

his views.

 

The proposed patch contains the active ingredient methylphenidate and would be

attached to a patient's skin for up to nine hourly daily. Methylphenidate is the

active ingredient in Novartis AG's ADHD drug Ritalin, and is also available as a

generic drug.

 

Paul Andreason, deputy director of the FDA's division of psychiatric products,

also said, in a presentation to the panel, the safety issues with the patch

" were roughly comparable " with other so-called stimulant ADHD drugs with the

exception of a small increase in tics, or involuntary movements like twitching.

 

However, FDA officials, including Dr. Levin, said the patch was effective at

controlling symptoms of ADHD in clinical studies that compared the patch to

Johnson & Johnson's Concerta, another ADHD drug, and a placebo, or fake patch.

 

The FDA previously rejected the patch in April of 2003 because it

" overmedicated children " and led to unacceptable adverse events " not associated

with the other once-a-day products available, " Dr. Andreason said.

 

Noven and Shire submitted a new application to the FDA earlier this year with

more information on the patch and proposed to have children wear the patch for

nine hours rather than 12 in order to address the FDA's concerns.

 

ADHD is a disorder in which people have difficulty concentrating or staying on

a task to the extent that it causes impairment in academic, work or social

settings. People with ADHD are often hyperactive and impulsive. An estimated 7%

of school-age children, or about four million children, are believed to have

ADHD.

 

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren.

 

URL for this article: http://online.wsj.com/article/SB113354493162512577.html

 

Copyright 2005 Dow Jones & Company, Inc.

 

 

 

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