Ionsys, a transdermal, patient-activated post-op pain control system that delivers fentanyl via electrical field, became subject to a Class 1 Drug Alert Sept. 29; the recall letter advises physicians to remove the device from patients immediately, provide alternative analgesia and monitor patients appropriately to detect potential symptoms of toxicity.
The company is looking into what would cause the device to self-activate in order to solve the problem and reintroduce Ionsys; it isn’t aware of any reports of harm to patients as a result, according to a published report by CNNMoney (note: this report is no longer available). The report also enumerates the hurdles facing introduction of the device to the American market:
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 Tuesday the FDA had rejected a supplemental application that was designed to clear the way for a U.S. 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.
The device, which was projected to generate nearly $120 million for J&J next year, is now delayed indefinitely.
