FDA gives green light to first ADHD patch

On Thursday, the Food and Drug Administration approved the first skin patch for the treatment of attention deficit hyperactivity disorder in children.

The patch, called Daytrana, contains methylphenidate and is designed to be worn on the skin for 9 hour durations. Methylphenidate has previously been shown to help children suffering from ADHD, and is the same stimulant found in Ritalin. Miami-based Noven Pharmaceuticals Inc. produces the patch, which it developed in collaboration with U.K.-based Shire Pharmaceuticals Group PLC.

Last December, a panel of independent experts, on behalf of the FDA, voted to recommend the patch’s labeling encourage its use as an alternative treatment for children between the ages of 6 and 12 diagnosed with ADHD, meaning physicians should only prescribe the patch if the children cannot take the drug in pill form. The patch, unlike ingested pills, can be removed if side effects occur.

A 12-hour version had previously been submitted to the FDA by Noven, back in 2003, but it was rejected by the agency and recommendations were made that the pharmaceutical company test a shorter-duration version, specifically a 9-hour version. Noven did so and the FDA approved it for use this week.

Thursday’s approval by the FDA comes at a time when methylphenidate use (along with other ADHD drugs) has increased. Over 3 million Americans under age 19 used drugs to treat their ADHD last year, according to Medco Health Solutions, Inc., a prescription drug benefit program manager.

The FDA in recent months has been grappling with the issue of stronger warning labels on these types of drugs, but a panel of outside experts recently recommended to the agency that the drugs bear labels which warn users in plain language about possible dangers, such as hallucinations or stroke.

Daytrana’s label, for the time being at least, will include standard warnings found on other products containing methylphenidate, including statements warning about insomnia, nausea, decreased appetite, and sensitization – where patients can develop antibodies resistant to the drug. Methylphenidate cannot be ingested in any form if this occurs.

In 2005, an FDA reviewer initially said that trials showed the patch produced troubling side effects too often to consider it safe for patients. Later, however, the reviewer told an expert panel that he had reconsidered and now judged the drug safe enough for approval. Afterward, the panel, the FDA’s Psychopharmacologic Drugs Advisory Committee, unanimously approved the patch.

The Daytrana patch will be available in 10, 15, 20 and 30 milligram, 9-hour dosages.

© Copyright 2007 Insight Journal Online Magazine.

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