A federal advisory panel determined Friday that the first skin patch to treat attention deficit hyperactivity disorder in children is both effective and safe, bringing the patch a step closer to regulatory approval.
However, the panel of independent experts voted to recommend to the Food and Drug Administration that the patch's label encourage its use as an alternative treatment for children with ADHD — in effect, saying doctors should prescribe it only if taking pills is too difficult for a child.
The unanimous vote by the FDA's Psychopharmacologic Drugs Advisory Committee, saying the patch was acceptably safe, came after a formerly critical FDA reviewer reversed his opinion about the drug.
The agency will now decide whether to approve the patch. It usually follows the advice of its advisory committees but is not required to. A decision is expected by Dec. 28, said a spokesman for U.K.-based Shire Pharmaceuticals, which developed the patch along with Noven Pharmaceuticals of Miami.
In documents posted by the FDA, agency reviewer Dr. Robert Levin had said that trials showed the patch produces troubling side effects too often to be considered safe. But on Friday, Levin told the committee he had reconsidered his opinion and now judged the drug was safe enough to approve.
The patch is designed to go on a child's hip for nine hours, according to submissions by the companies that developed it. It releases into the body methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin.
The patch is designed for children between the ages of 6 and 12. The developers said it is a way to treat ADHD in children for whom taking pills is difficult or unpleasant. Unlike a pill, it can be removed from the body if it causes harmful side effects.
Some children who received the patch during trials reported decreased appetites, headaches, insomnia, nausea and tics, the FDA said. These occurred more often than in children taking Concerta, a pill that uses methylphenidate, and others taking a placebo. Some in the patch test also had skin irritation.
In documents submitted to the FDA, the developers of the patch said it was safe and that problematic side effects were similar to those occurring in children who take methylphenidate orally.
Shire spokesman Matt Cabrey said he was surprised that the FDA's reviewer changed his mind and pleased with the outcome.
It is the second time Noven has submitted the patch to the FDA. In 2003, The agency rejected a previous proposal for a 12-hour patch, and recommended Noven test the patch with a nine-hour application.
But in the FDA documents, Levin had written the nine-hour patch "does not appear to be significantly more acceptable" than the 12-hour version. "Generally, it appears that the identical safety concerns remain," he wrote.
The patch would be sold under the name Daytrana.
By John J. Lumpkin