The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami.
In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
Unlike pill forms of the drug, the patch can be removed if it causes side effects.
Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday.
U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals.
Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear.
The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.
"We feel that the labeling approved with this product is adequate and adequately provides for safe and effective use," said Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products. The companies have pledged to study the sensitization issue, he added.
Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve.That panel, the FDA's Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.
The patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, Laughren said. The patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate.
The patch will be available in four doses: 10, 15, 20 and 30 milligrams per nine hours, Laughren said.
By ANDREW BRIDGES