Daytrana Patch for Attention Deficit Wins FDA Approval

The first skin patch to treat attention deficit hyperactivity disorder in children will be sold under the name Daytrana. Designed to be worn for 9 hours, the ADHD patch contains methylphenidate, the same stimulant as that in Ritalin.

On Thursday, the US Food and Drug Administration formally approved the world’s first transdermal methylphenidate delivery system — the ADHD patch, to be sold under the name ‘Daytrana’.

As we reported in “ADHD Patch to be Sold as Daytrana”, the patch manufacturer had initially proposed a 12-hour version, but it is the 9-hour version which has been approved, in four doses: 10, 15, 20 and 30 milligrams. The ADHD patch will be labelled as an alternative treatment for children ages 6 to 12 years.

A report carried by the APA notes that the approval is not without controversy: apparently, the patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, and the ADHD patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate. The APA story reports:

Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve. That panel, the FDA’s Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.

That story also mentions that:

The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.

Several readers have expressed a keen interest in this new ADHD treatment, and we sincerely hope that Daytrana will prove helpful for them and their families.

Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions

All clinical material on this site is peer reviewed by one or more clinical psychologists or other qualified mental health professionals. This specific article was last reviewed or updated by on .

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