Transdermal Iontophoretic FentaNYL PCA

摘要

In 2015, The Medicines Company announced the U.S. Food and Drug Administration (FDA) had approved IONSYS, a patient-controlled transdermal iontophoretic system that releases fentaNYL on demand. The system is composed of a plastic housing that contains the battery and a separate hy-drogel reservoir that contains fentaNYL. The patient activates a dose by pushing a button twice on the credit card-size device that adheres to the skin, which causes an imperceptible electrical current that drives fentaNYL through the skin by iontophoresis. The product is limited to hospital use only, for short-term management of acute postoperative pain in adult patients. Ionsys was first approved by FDA in 2006 but was never marketed in the United States. It had been marketed in Europe but was withdrawn due to corrosion that might cause release of fentaNYL without pushing the button. The company told us improvements have been made to address this issue. Still, in the Supplemental New Drug Application approved by the U.S. FDA, the company was called upon to monitor this possibility and submit findings regularly. The company said no changes have been made to dosing information in the previously approved labeling. Each activation delivers 40 meg of fentaNYL over 10 minutes, up to six times an hour. Thus, up to 240 meg per hour can be administered and drug delivery can be activated up to 80 times per 24 hours. Excessive button pushes can lead to serious injury. The used device is removed and replaced every 24 hours for a maximum duration of therapy of 72 hours.