Ritalin Patch Awaiting Approval

Ritalin label
Kids who are prescribed ADHD drugs may soon have a choice: the patch or the pill.

A new patch system delivers methylphenidate — the main ingredient in Ritalin, Concerta, and Methylin — throughout the day. Made by Noven and Shire pharmaceutical companies, the patch is the first ADHD drug that does not have to be taken orally. Pending FDA approval, the companies plan to call the patch Daytrana.

Studies reported at this week's joint meeting of the American and Canadian Academies of Child and Adolescent Psychiatry find the patch works at least as well as the popular once-a-day ADHD drug. Sharon B. Wigal, Ph.D., director of clinical trials at the Child Development Center at the University of California, Irvine, led one of the studies.

"The patch is different from oral stimulant medications, where the longest action is up to 10 or 12 hours. It looks like the patch goes beyond that," Wigal tells WebMD. "This is a plus, because this may really allow you to formulate a dose for individual patients. Even though we were removing the patch after nine hours, once parents administer it themselves they may determine to remove it earlier or later. That may give them more options, knowing there was continuing efficacy beyond that 12-hour time point."

Better Behavior, Attention, Math Scores

Wigal led a research team that gave the patch to 80 ADHD kids aged 6 to 12. Half the kids got an inert placebo patch and later switched to a real patch; the other half started with a real patch and later switched to a placebo.
When getting the real patch, the children's ADHD was significantly better than when they got the fake patch. Their behavior and attention, tested throughout the day, improved. They also did better on age-adjusted math tests.

The patch does have side effects.

"It is pretty comparable to what we see with other stimulant drugs," Wigal says. "We do see effects on sleep onset and decreased appetite. And then, because this is a transdermal system, you may see a skin response. That would be something to look at if a child is more sensitive in terms of skin type."

Children in the study are continuing to use the patch for a full year. So far, the patches aren't much of a problem.

"We see continued maintenance in terms of the patch continuing to work and safety not being a concern," Wigal says.

Better Than Extended-Release Pills?

In a second study, Robert L. Findling, MD, director of child and adolescent psychiatry at University Hospital in Cleveland, led a team that compared the patch with placebo as well as with methylphenidate pills.

Compared with placebo, both the patch and methylphenidate pills improved 6- to 12-year-old kids' ADHD. Interestingly, ADHD scores improved more with the patch than with the pills, although the difference was not large enough to be considered scientific proof of superiority.

"In general, there was a trend toward a greater positive effect of treatment with [the patch] than [oral medication]," Findling and colleagues write in their presentation abstract.

Who Would Use the Patch?

Since the patch contains the same drug as other long-lasting ADHD drugs, why would a parent choose it? WebMD asked Leslie Rubin, MD, director of developmental pediatrics at Emory University School of Medicine.
Rubin remembers the sea change in ADHD treatment that methylphenidate brought about some 10 years ago.

"That was a revolution, because a child would get Ritalin and go to school, and by 11 a.m. it is not working any more," Rubin tells WebMD. "So we would have to prescribe another dose at school, and there would be long lines at the nurse's station. It was disruptive — and the kids would get embarrassed."

Concerta, Rubin says, also solved some of the problems that haunted early extended-release versions of ADHD drugs. So why go to the patch?

"Well, some kids don't like to take pills or even liquids. And you can't break up extended-release pills and put them in applesauce — you destroy the release mechanisms," Rubin says. "If approved by the FDA, the patch will offer an opportunity to give an ADHD medicine without the child having to swallow it."

Perhaps more importantly, the patch offers more control over how long a parent wants the stimulant medication to last.

"If you give a child a pill, it is in the body and you can't do anything about it," Rubin says. "But if you put the patch on, and the child needs, say, six hours today, you can leave it on for a corresponding amount of time."

Wigal agrees. She says the patch may release methylphenidate for as long as 16 hours. Her team is also studying what happens when the patch is removed at times shorter and longer than those used in the this study. So far, she says, it looks as though the patch must be removed for three hours before its effects wear off.

Sources: 2005 joint meeting of the American Academy of Child and Adolescent Psychiatry and the Canadian Academy of Child and Adolescent Psychiatry, Toronto, Oct. 18-23, 2005. Sharon B. Wigal, PhD, associate clinical professor of pediatrics and director of clinical trials, Child Development Center, University of California, Irvine. Leslie Rubin, MD, director of developmental pediatrics and associate professor, Emory University School of Medicine.
By Daniel J. DeNoon
Reviewed by Louise Chang, MD
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