Noven ADD drug patch criticized by FDA regulator

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A staff physician with the Food and Drug Administration says a medicated patch made by Noven Pharmaceuticals may pose harm to children.BY KERRY DOOLEY YOUNGBloomberg News
Noven Pharmaceuticals' application for the first drug patch to treat attention deficit disorder shouldn't be cleared for U.S. sales because it may harm children, a regulator said Thursday.
The patch can cause insomnia and tics and may stunt growth, said the regulator, Robert Levin, a staff physician with the Food and Drug Administration. Miami-based Noven's shares fell as much as 23 percent after Levin said his agency should reject the patch, which contains generic Ritalin, or methylphenidate.
An outside panel meeting today may nonetheless recommend that the FDA approve the patch, said Ira Loss, an analyst with Washington Analysis, who advises institutional investors. A senior agency official also said the patch may be a welcome alternative to pills for some of the 2 million U.S. children with the disorder, which makes it hard for them to concentrate.
''It's going through despite the objections of the reviewer,'' Loss said Thursday in a telephone interview. ``If the side effects are a problem, you can take the patch off. When you take the pills, you are stuck until the medication wears off.''
The committee, which includes doctors who treat children with attention deficit disorder, will meet in Gaithersburg, Maryland, outside Washington.
Levin's comments were part of a staff review before the meeting.
One obstacle to approval is growing agency concern over drug patches, analysts say. The FDA issued warnings this year about cases of users receiving excess doses of birth control and pain medicines.
''The current FDA environment for patches is less than optimal given recent problems,'' said Scott Henry, an Oppenheimer & Co. analyst in Boston, in a Nov. 29 report.
Noven shares fell $2.34, or 17 percent, to $11.17 in Nasdaq Stock Market composite trading. Shares are down 25 percent this year.
The FDA in April 2003 rejected Noven's initial request to approve the patch. The agency then had concerns about insomnia, loss of appetite and weight and potential slowing of growth for children using the Noven patch.
Noven and its partner, Shire Plc, based in Basingstoke, England, have since presented two studies. Neither was ''significantly more acceptable than'' previous research, Levin said.
Thomas Laughren, head of Levin's division, was more positive.
''The patch formulation may offer some advantages over existing oral formulations, e.g., ease of administration for those who have difficulty with pill-taking, lack of interaction with food intake, and an ability to terminate the effects by removal of the patch,'' Laughren said in his memo.
If approved, the Noven patch will have a hard time competing against pills, said Andrew Adesman, chief of developmental and behavioral pediatrics at Schneider Children's Hospital in Lake Success, New York.
Children may take off their patches, reducing the amount of medicine they get, Adesman said in a telephone interview Wednesday. Doctors and parents won't be able to keep children from sharing patches.
Doctors say the introduction of Johnson & Johnson's Concerta, a once-daily form of the drug, in 2000 already has made it easier for children to go about their school day without interruption.
''It made those lines that formed around the nurse's office at lunch time a thing of the past,'' said Lawrence Diller, a psychiatrist in Walnut Creek, California, and author of Running on Ritalin and Should I Medicate My Child?
The FDA in September stopped reviewing a Noven application for a generic version of Johnson & Johnson's Duragesic patch, which delivers the painkiller fentanyl. The agency had concerns about the higher drug content in the Noven version.