FDA approves 1st patient-controlled patch for postoperative pain management

The FDA has approved Ionsys, a fentanyl iontophoretic transdermal system from the Medicines Co., according to a Medscape report.

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Ionsys is the first needle-free, patient-controlled fentanyl delivery system designed for postoperative pain management.

Ionsys’ efficacy was examined in three placebo-controlled trials. The device’s safety was examined in an additional three placebo-controlled trials and four active-controlled randomized trials.

Ionsys is expected to become available in the United States later this year, according to the report.

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