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FDA panel supports ADHD patch with limits

December 2, 2005

By Susan Heavey

GAITHERSBURG, Maryland (Reuters) – An experimental patch to treat children with attention deficit hyperactivity disorder (ADHD) is safe and effective but should carry certain warnings, a U.S. advisory panel unanimously said on Friday.

The panel’s decision came after a key Food and Drug Administration reviewer reversed his earlier recommendation that the patch, made by Britain’s Shire Pharmaceuticals Group Plc and U.S.-based Noven Pharmaceuticals Inc, was too risky.

FDA officials are considering whether to approve the patch, which contains a generic version of one of the most popular ADHD treatments — Novartis AG’s Ritalin.

The FDA usually follows its advisers’ advice and is expected to rule by December 28.

Panelists said the patch, known as the methylphenidate transdermal system (MTS), should only be used after children have tried pills or by those who have trouble taking them. They said the packaging should include that suggestion but stopped short of recommending a formal restriction.

“I don’t see any acute, imminent risk,” said panel chairman Wayne Goodman, a University of Florida psychiatrist, but he added “there is unanimous agreement that we would like to see some studies conducted.”

In 2003, the FDA rejected an earlier bid to sell the patch, citing high rates of insomnia, anorexia and weight loss when worn for 12 hours compared to a placebo patch.

Shire and Noven conducted more studies and are now seeking approval for nine hours of daily use in children ages six to 12 under the trade name Daytrana.

Shares of Noven, which had fallen 17 percent to $11.17 on Thursday, were halted on the Nasdaq market on Friday. In London Stock Exchange trading, Shire shares closed up 4 percent.

Robert Levin, a staff reviewer in the FDA’s Division of Psychiatry Products, told panelists on Friday he had changed his earlier opinion, released on Thursday but dated November 7.

Robert Temple, head of the FDA’s Office of Medical Policy, told the panel the reversal was not unusual.

“This won’t be the first time people changed their mind along the way,” he said.

Shire spokesman Matthew Cabrey said negotiations with the FDA would continue.

During the meeting, Shire officials said the patch offered parents and doctors flexibility and should not be restricted. Side effects were no worse than those found with similar pills, they added.

Ritalin and other methylphenidate drugs are stimulants, and are some of the most abused drugs among youth.

FDA staff said patch abuse was unlikely because it takes about two hours to kick in. But some panelists questioned whether it could be reused or cut up and chewed.

Shire said the companies recognized the potential for abuse and would set up a monitoring program.


Source: reuters



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