Oral methylphenidate drugs should be considered prior to selecting Shire/Noven's Daytrana patch for treatment of attention deficit/hyperactivity disorder due to concerns about skin sensitization, FDA's Psychopharmacologic Drugs Advisory Committee said at its Dec. 2 meeting.

"Given the uncertain knowledge regarding the risks of sensitization, consideration should be given to prescribing oral forms of methylphenidate prior to prescribing" the methylphenidate patch, Committee Chair Wayne Goodman (University of Florida) said.

[Editor's note: To ¹ watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]

The committee said the language should follow the example of Pfizer's Geodon (ziprasidone) labeling, which urges consideration of other antipsychotic therapies that do not have the potential for cardiac QT interval prolongation.

The committee rejected a proposal to restrict Daytrana use in labeling to those patients who are unable to take oral drugs by an 11-to-1 vote.

The committee members agreed that the methylphenidate patch should carry strong warnings concerning the potential for future allergic reactions to other oral methylphenidate products if a user experiences an allergic skin reaction to the patch. Such a reaction could lead physicians to stop prescribing methylphenidate products for those patients.

Most committee members, however, stopped short of recommending a boxed warning on the skin sensitization side effect.

The committee meeting took an interesting turn early on when FDA's clinical reviewer reversed his previous view on approvability of Daytrana.

In a pre-meeting briefing document, FDA Clinical Reviewer Levin recommended against approval of the patch, citing increased incidence of insomnia, anorexia, decreased appetite and the potential for skin sensitization.

Levin additionally said a number of the events were higher in incidence than Johnson & Johnson/Alza's oral extended-release methylphenidate product Concerta (² Also see "Shire/Noven's Daytrana Receives FDA Wake-up Call: Side Effects Greater Than Concerta, Agency Says" - Pink Sheet, 1 December, 2005.).

At the meeting, Levin was urged by the committee to explain his change of heart.

"One of the main reasons for changing my recommendation is because" there is more data available, Levin said.

Levin continued: "One of the reasons I've changed my thinking is that it is clear that almost all, if not all, of these [adverse events], other than skin sensitization events,…are consistent with those" of other methylphenidate products.

"Even though I did say significant differences than Concerta , it was not a statistical difference. Upon further review, I don't think it's a widely different range of adverse events," Levin concluded.

Noven originally submitted the NDA for the methylphenidate patch (then Methypatch ) on June 27, 2002.

FDA deemed the application "not approvable" in April 2003 due to concerns about adverse events and the potential for skin sensitization and recommended that Noven conduct new studies with reduced patch wear-time. The NDA was resubmitted on June 28, 2005; the user fee date for the application is Dec. 28.

- Danielle Foullon, Jonathan Block

Shire/Noven Daytrana Second-Line? Physicians Should Consider Oral Agents First, Cmte. Says

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