American Launch of J&J Pain Device Delayed on Heels of European Recall
Johnson & Johnson has recalled a pain-management device from Europe due to a potential self-activation defect that could lead to overdose. The Ionsys device's U.S. launch has been delayed.
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. The report also enumerates the hurdles facing introduction of the device to the American market:
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.
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