Europe Clears J&J Pain Patch

The company's Alza unit gets regulatory approval for the Ionsys.
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Johnson & Johnson's

(JNJ) - Get Report

Alza subsidiary has received European regulatory approval for its new Ionsys transdermal pain patch.

Approval of the battery-powered patch, intended for acute moderate to severe post-operative pain, follows the expiration of J&J's U.S. patent on its Duragesic pain patch a year ago. Both patches contain the drug fentanyl hydrochloride, which is administered through the skin.

With the Ionsys patch, patients can self-administer their medication by pressing a button that activates a small electrical current to deliver a preprogrammed dose of the drug.

After the Duragesic patent expired, J&J's pharmaceutical sales took a hit as generic-drug maker

Mylan Laboratories

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jumped on the opportunity to grab a piece of the market and came out with its own version of the pain patch. Last summer, the Food and Drug Administration issued a public health advisory on fentanyl patches and said it was investigating about 120 deaths that may be related to their use.

Alza initially sought approval for Ionsys in a September 2003 application, but was asked to provide more information on the patch in mid-2004 before it could be cleared. Alza resubmitted its application late last year.

J&J's shares dipped 52 cents to $58.19 Monday.