The committee gave its unanimous backing to the product, known as Daytrana, despite earlier concerns by FDA officials that its benefits did not outweigh its risks. But experts also unanimously urged that doctors only prescribe the patch to children who can't take pills.
The FDA isn't required to follow the recommendation of its advisors, but it usually does.
The patch, about half the size of a credit card, is designed to deliver a nine-hour dose of methylphenidate, the same stimulant drug found in Ritalin, Concerta, and other pills. Manufacturers said the patch would provide a treatment option to an estimated 15% of children 6-12 years old with ADHD who can't or won't take pills.
"If families and the children aren't really being compliant with the med treatment then it really doesn't matter how many medications are out there," said Sharon Wigal, PhD, an associate clinical professor of pediatrics at the University of California, Irvine. She testified on behalf of the companies.
"If this is a treatment that parents will adhere to ... that really means something," she said.
Between 3% and 5% of U.S. school-aged children are thought to have ADHD. Children with the most common form of the disorder can act out and have trouble staying mentally focused, leading to poor school performance and behavioral problems.
Millions of American children now take methylphenidate and other stimulant drugs to treat ADHD and related disorders.
Second Try for Approval
The patch has been shown to reduce ADHD symptoms about as well as other oral treatments. But the FDA rejected the patch in 2003 because concerns over insomnia, tics, weight loss, and other side effects outweighed its benefits.
Noven Pharmaceuticals and Shire Pharmaceuticals, which are seeking to jointly market the patch, told FDA advisors that a new form delivering medication for nine hours is safer than the previous 12-hour form.
Agency safety officials initially took a dim view of the newer patch, expressing concern that the same side effects seen in the older patch were still an issue. Safety reviewer Robert Levin, MD, wrote in a brief presented Friday that the FDA should declare Daytrana "not-approvable."
But Levin told committee members at the hearing that he had "reconsidered" his review and now recommended clearing the patch for marketing because most of the initially troubling side effects are similar to those commonly seen with other ADHD drugs.
"It's clear that almost all of these, if not all ... are consistent with those labeled in other methylphenidate products," he said. "I think it's ... a reasonably safe treatment in this population," Levin added.
Allergic Reaction Concerns
Levin and other FDA officials said they were still concerned about results showing that the patch may cause sensitivity reactions that could make patients unable to take any methylphenidate drug.
About half of children who used the patch in clinical trials experienced skin reactions. Most of the reactions were mild, but at least one of 270 had an allergic response that made it unsafe to take any other methylphenidate drug.
Experts expressed concerned that the risk of allergic reactions -- which remains largely unknown -- could cause large numbers of permanent allergies to a drug taken by millions of American children.
Panelists unanimously urged the FDA to require the companies to study the risk of allergic skin reactions once Daytrana reaches the market and to urge doctors to reserve it only for children who can't or won't take pills.
"I'm not comfortable going on the record as it being first-line therapy," said Barbara G. Wells, dean of the University of Mississippi School of Pharmacy and a panel member.
Thirteen percent of children in a company study experienced insomnia using the patch, compared to 8% who took the competitor drug Concerta in pill form. Children taking the drug lost an average of 2.2 pounds after seven weeks of using the patch.
Shire spokesman Matthew P. Cabrey said the company was likely to advertise Daytrana directly to consumers if it gains FDA approval.