FDA Panel Backs Approval of ADHD Patch
Experts Recommend That Daytrana Should Be Used By Kids Who Can't Take Pills
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.