Johnson & Johnson Recalls Pain-Drug Device In Europe

Johnson & Johnson has recalled a pain-drug device from the market in Europe due to a potential defect that could lead to overdose, and the company faces new hurdles launching the product in the United States.

The setbacks have prompted some Wall Street analysts to further reduce expectations for what was once viewed as a promising new pain product, Ionsys.

In late September, J&J recalled Ionsys from certain European countries because some were found to self-activate, which has the potential to cause an overdose, according to a J&J letter to doctors that was posted on the Web site of the U.K. Medicines and Healthcare Products Regulatory Agency on Sept. 29.

Ionsys is a needle-free device that attaches to the skin and delivers the drug fentanyl through the skin via an electrical field. It is supposed to be activated by the patient with the push of a button to control pain following surgery in the hospital.

J&J, in New Brunswick, NJ, began selling Ionsys in Germany, the U.K. and Ireland in January, and subsequently expanded it to some other European countries.

In its recall letter to doctors, J&J said the device should be removed from patients immediately, and that unused stock should be returned to distributors for refunds.

The company is now looking into the cause of the potential defect, said spokeswoman Gloria Vanderham. J&J isn’t aware of any reports of harm to patients as a result of the potential defect.

J&J plans to solve the problem and reintroduce the product whenever possible, said Paul Stoffels , company group chairman of global research and development.

It’s not the first time J&J has recalled a fentanyl-based product. In February, J&J said it would recall in the U.S. a version of Duragesic, a fentanyl-based skin patch, because of manufacturing problems that could lead to respiratory depression or possible overdose. Duragesic had $1.16 billion in 2007 sales. Even before the February Duragesic recall, J&J had been sued over alleged overdoses caused by the product; there were at least 60 such claims pending as of June 30.

Meanwhile, J&J still hasn’t launched Ionsys in the U.S., despite getting Food and Drug Administration approval in May 2006. And now it appears the product won’t hit the market any time soon; J&J said the FDA had rejected a supplemental application that was designed to clear the way for a US launch.

J&J has previously said the launch was delayed by manufacturing challenges. Last year, the company indicated it had resolved the manufacturing problems, and earlier this year J&J submitted the so-called “manufacturing supplement” application for an FDA go-ahead.

J&J now is evaluating a “next-generation system,” said Louise Mehrotra , head of investor relations.

Wachovia Capital Markets previously estimated that Ionsys could generate about $117 million in 2009, rising to $581 million in 2012. But analyst Larry Biegelsen said in a note to clients that the product has been delayed indefinitely and he has removed sales estimates from his forecast.

SOURCE: Dow Jones Newswires