The FDA granted approval in April for a product that delivers methylphenidate (the active ingredient in Ritalin) through a "transdermal delivery system" - a skin patch.
Two pharmaceutical companies, Noven and Shire, managed to win approval last month for a product that delivers methylphenidate (the active ingredient in a number of ADHD drugs) through a "transdermal delivery system," or skin patch, according to a press statement released by Shire US Inc. on April 6th.
In a statement the day the drug was approved Food and Drug Administration (FDA) mentioned one aspect of the new drug's use that may change the way ADHD is treated:
"The prescriber (doctor) may change the amount of time the patch is worn to help manage how long the medication works each day and some of the side effects that may be caused by methylphenidate."
In other words, while the Daytrana patch is intended to be worn for nine hours, a doctor could instruct parents to take it off sooner or leave it on longer. The patch is thought to be effective for at least 12 hours -- and maybe as long as 16 hours. That gives parents much more control and flexibility in using the medication. If side effects become too much of a problem the patch can simply be removed. That's an advantage over traditional ADHD medications, since you can't "unswallow" a pill two or three hours after you take it.
While parents may eventually look to Daytrana as the product of choice for ADHD, at the moment the FDA has is asking doctors to consider it an alternative medication to drugs currently in use. All of those drugs are available as pills or liquids; Daytrana is intended for children who have trouble swallowing medication.
Daytrana has been a long time coming. The FDA rejected an application by Noven for a skin patch for ADHD in 2003. In early December of 2005 a reviewer at the FDA gave Daytrana a poor review. A few days later the reviewer changed his mind. And on December 5th, the FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously that Daytrana had been shown to be effective for the treatment of ADHD and that it was "acceptably safe."
How safe is that? One of the issues that make ADHD so controversial is that the medications for the disorder all put children at relatively high risk for a number of side effects and long term problems. There is a high potential for abuse of methylphenidate and it may lead to "severe psychological or physical dependence." The Drug Safety and Risk Management Advisory Committee, which advises the FDA, voted 8 to 7 in February to add a "black box" warning to some ADHD drugs. The panel was concerted with the possibility that the drug may cause heart problems. About 2.5 million children take some form of methylphenidate for ADHD; 20 have died from heart related problems.
Methylphenidate has a number of known side effects: reduced appetite, headache, nervousness or "jittery" feelings, stomach problems, sleep difficulty, depression, anxiety, and even more profound mental health issue. All of those problems seem to be as common with Daytrana as with any other ADHD medication.
Still, the flexibility of a skin patch may make Daytrana the drug of choice for ADHD in the not too distant future.
Daytrana will become available in June or July of 2006.
(Suite 101 offers more on ADHD. Greg Cruey is not a medical doctor and discusses the use of ADHD drugs as an educational issue.)
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