NEW YORK (CNNMoney.com) - A new treatment for hyperactive kids, one that uses a skin patch instead of a pill, is meeting resistance with regulators.

Noven Pharmaceutical, a Miami-based drug maker specializing in skin patches, is awaiting a regulatory decision on Methypatch, a treatment for attention-deficit hyperactivity disorder for children ages 6 to 12. But Noven got some bad news from the Food and Drug Administration Thursday morning.

Dr. Robert Levin, director of the FDA's division of psychiatry products, wrote that Methypatch is effective in treated ADHD but "cannot be safely marketed, even the with nine-hour wear time," according to documents released by the FDA Thursday.

Levin's statement is not considered a final decision. An FDA advisory committee will vote on Friday whether to recommend approval of Methypatch for the treatment of ADHD. The FDA usually follows the advice of its expert advisory panels.

"If there's any safety issues, this is not likely to pass muster with the FDA advisory panel," said Ken Trbovich, analyst for RBC Capital Markets who rates Noven neutral. "For Noven, it's particularly bad, because this is now the second instance where the FDA is indicating that their patch technology is not providing a sufficient margin of safety."

Noven (unchanged at $13.51, Research), which has several estrogen patches on the market, has not had an easy time trying to get Methypatch approved. The original new drug application was submitted June 27, 2002, but a non-approval letter was sent to the company on April 25, 2003, according to the FDA. Noven submitted the newest drug application on June 28, 2005.

Noven was not available for comment.

Methylphenidate, a stimulant affecting the nervous system, is the same compound used in Ritalin, which has been off-patent for decades, and Johnson & Johnson's (unchanged at $61.75, Research) Concerta. Novartis (unchanged at $52.40, Research) currently markets methylphenidate as an extended-release, once-daily pill under the brand name Ritalin LA.

Methylphenidate is sometimes abused for its euphoric effects, according to the National Institutes of Health. Abusers have been known to chop up the pills and snort them.

ADHD affects up to 5 percent of children in the United States, according to the NIH. Children with the disorder show patterns of increased activity, impulsive behavior and inattention.

To find out more about the risks associated with ADHD treatments, click here.