Subanalysis finds patient-controlled, transdermal pain management system may be comparable

Phoenix, Arizona, November 15, 2004 - Researchers have reported that IONSYSTM, a novel patient-controlled, transdermal, analgesic system that delivers fentanyl through the skin, may be comparable to intravenous patient-controlled analgesia (IV PCA) when used after gynecologic surgery. This needle-free system for managing acute pain in the hospital setting is currently under review by the Food and Drug Administration (FDA), and was granted approvable status in June, 2004. These data were presented at the American Society of Regional Anesthesia & Pain Medicine Annual Fall Pain Meeting.

This research is a subanalysis of a broader, head-to-head study published earlier this year in the Journal of the American Medical Association (JAMA). The complete set of data showed that 316 adult patients receiving IONSYSTM following major surgery experienced similar pain relief as that experienced with IV PCA morphine. This subanalysis focuses on the women in the study who had undergone gynecologic surgery. Patients received either IONSYSTM fentanyl HCl 40mcg -- a system that is designed to be the first and only needle-free, patient-controlled, transdermal analgesic to treat acute pain -- or the current standard of therapy, morphine via IV PCA. IONSYSTM currently is under development and not yet commercially available.

Researchers reported no statistically-significant differences between the two methods in patients' overall pain control, the amount of supplemental pain medication required, or the number of patients withdrawing from the study due to inadequate pain relief. Side effects were similar in both groups.

"In 2002, there were more than a million gynecologic surgeries performed in the United States," said Shireen Ahmad, M.D., Assistant Professor, Department of Anesthesiology at Northwestern University. "In this subanalysis, IONSYSTM provided post-operative pain relief to most patients und


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