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Daytrana: A Long and Winding Road to Approval

Daytrana: A Long and Winding Road to ApprovalOn April 6, 2006, the FDA announced the approval of Daytrana, a transdermal patch version of Ritalin (methylphenidate).

While you wouldn’t know it by the gushy promotional copy on Daytrana’s website (www.daytrana.com), the Ritalin patch just barely squeaked through the FDA approval process.

The product was originally submitted for FDA approval in June of 2002 by an obscure company called Novum Pharmaceuticals (which has since partnered with Shire to handle Daytrana’s marketing chores). The application included data on children with ADHD who wore the patch for 12 hours a day. While the patch effectively treated ADHD symptoms, the FDA rejected the application because it caused a very high rate of side effects – an astounding 61% rate of appetite loss and 47% rate of insomnia in one study (J Am Acad Child Adolesc Psychiatry 2005;44(6):522-529).

In frenetic post-rejection meetings, the FDA advised Novum to try again, but this time to test a wear time of 9 hours instead of 12. Two years later, the FDA reviewed the resubmitted application, and the chief medical reviewer, Robert Levin, M.D., still didn’t like it, and recommended that it be rejected all over again! (See http://www.fda.gov/ohrms/dockets/ac/ 05/briefing/2005-4195B1_02_02-FDAClinincal- Review.pdf). Levin’s problem with the new data was similar to the initial rejection – too many side effects, especially nausea, poor appetite, insomnia, and tics.

Luckily for Novum, less than a month later, at the crucial meeting of the Pharmacologic Drugs Advisory Committee, Levin changed his mind, testifying that the drug did not cause as many side effects as he thought.

At issue was whether Daytrana caused significantly more side effects than Concerta, which was the active comparator in one of the two trials. In fact, Daytrana did cause a somewhat higher rate of insomnia, appetite loss, and nausea than Concerta, but the differences weren’t statistically significant. Of particular concern to Levin was Daytrana’s 7% incidence of tics, vs. Concerta’s 1%. But on closer review, some of the adverse events coded as tics may have been random tongue movements unrelated to the drug; and, at any rate, most of the “tics” resolved on their own with continued treatment.

By the way, Novum/Shire never did get around to submitting the Daytrana vs. Concerta study for publication; given the damning side effect numbers, it’s easy to see why! Interested readers can view the data by plowing through the 53-page clinical review on the FDA’s website at the URL already cited above.

At any rate, despite Daytrana’s checkered regulatory past, it’s now a bona fide FDA approved medication, available for about $170/month at your local pharmacy.

Should psychiatrists prescribe it?

Probably not, for a number of reasons. According to the package insert, it has a lag time of 3.1 hours between application to the hip and release of Ritalin into the serum. That means that Johnny will have to wake up very early in order to derive any benefits during the important morning school hours. Clinicians will be tempted to compensate for this failing by prescribing a small dose of oral Ritalin in the morning, defeating the whole purpose of the patch, which is marketed for kids who hate to take pills.

In addition, the patch’s wear time of 9 hours means a trip to the nurse in the afternoon, depriving the student of one of the main benefits of long-acting agents – take it once in the morning with no interruption of the school day for extra health visits.

Finally, there already exist several more convenient options for pill-phobic kids. These include extended-release Ritalin LA, Metadate CD, and Focalin XR, all of which are capsules filled with beads that can be sprinkled over food. There are also two easily ingested versions of immediate-release Ritalin: Methylin CT (a chewable tablet) and Methylin Oral Solution.

TCR VERDICT: Daytrana: They shouldn’t have bothered applying twice!

Daytrana: A Long and Winding Road to Approval

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This article was published in print 9/2006 in Volume:Issue 4:9.


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APA Reference
Psychiatry Report, T. (2013). Daytrana: A Long and Winding Road to Approval. Psych Central. Retrieved on December 11, 2018, from https://pro.psychcentral.com/daytrana-a-long-and-winding-road-to-approval/

 

Scientifically Reviewed
Last updated: 14 Aug 2013
Last reviewed: By John M. Grohol, Psy.D. on 14 Aug 2013
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