A patient-activated transdermal product for short-term management of acute postoperative pain in adults requiring opioid analgesia has received Food and Drug Administration approval.
The fentanyl iontophoretic transdermal system, marketed under the trade name IONSYS by Alza Corp., was approved for use only in hospitalized patients.
In an interview, Dr. Eugene R. Viscusi, director of regional anesthesia and acute pain management at the medical school of Thomas Jefferson University, Philadelphia, described IONSYS as a compact, preprogrammed, needle-free system that provides an alternative to administering morphine via intravenous patient-controlled analgesia (PCA).
Each unit is about 2 by 3 inches, with adhesive backing and a dosing button. The patient double clicks the button when analgesia is needed, and 40 mcg of fentanyl is delivered over 10 minutes.
The approval of IONSYS and of DepoDur, a sustained-release injectable morphine for epidural use approved in 2004, illustrates the movement of postoperative analgesia “into this realm of less invasive and less burdensome technologies” that are more user-friendly and less cumbersome for patients and nursing staff, noted Dr. Viscusi. He has served as a scientific adviser to Alza, which has provided research support to Thomas Jefferson University.
IONSYS is applied to intact, nonirritated, nonirradiated skin on the chest or upper outer arm, and is replaced every 24 hours or when 80 doses have been administered. A maximum of 6 doses per hour and 80 doses over 24 hours can be administered; no more than 1 dose every 10 minutes can be released. Patients should be titrated to comfort before starting treatment, the label says.
IONSYS was compared with placebo or with IV PCA morphine in seven studies of 3,392 patients (2,114 using IONSYS) aged 18–90 years, with body types ranging from very thin to obese. In those studies, IONSYS provided effective acute pain management after a variety of surgical procedures, including orthopedic, general, and gynecologic surgery, according to Dr. Viscusi. The most common adverse effects among those treated with IONSYS included nausea, vomiting, application site-related erythema, fever, and headache.
Dr. Viscusi was the lead author of a study in which more than 600 postoperative adult patients were randomly assigned to either IONSYS or IV PCA. The patients rated the two approaches “as basically therapeutically equivalent” in terms of pain control after 24 hours of treatment, he said. Opioid-related side effects were comparable in the study (JAMA 2004;291:1333–41).
Other aspects of the transdermal system have not been directly compared with IV PCA, but because IONSYS is compact, self-contained, and needle-free, Dr. Viscusi believes that it should be easier to use, won't impede physical therapy or patient activity, and will reduce the risk of medication errors, compared with IV PCA.
Fentanyl is a schedule II drug with a high potential for abuse.
IONSYS is a compact, preprogrammed, needle-free system that provides an alternative to administering morphine intravenously. Ortho-McNeil, Inc.