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http://online.wsj.com/article_print/SB113354493162512577.html [subscription needed]
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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