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
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
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
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
Meanwhile, J&J still hasn't launched Ionsys in the U.S., despite getting Food and Drug Administration approval in
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
Wachovia Capital Markets previously estimated that Ionsys could generate about
SOURCE: Dow Jones Newswires