Johnson & Johnson's affiliate Alza has received the FDA's nod for Ionsys (fentanyl iontophoretic transdermal system), a needle-free, patient-activated analgesic system. Ionsys will be the first product to utilize Alza's proprietary E-Trans system, which employs iontophoresis, a process in which a low-intensity electric field is used to transport the drug (fentanyl) across the skin and into the circulatory system.
New fentanyl delivery system for in-hospital use
Johnson & Johnson's affiliate Alza has received the FDA's nod for Ionsys (fentanyl iontophoretic transdermal system), a needle-free, patient-activated analgesic system. Ionsys will be the first product to utilize Alza's proprietary E-Trans system, which employs iontophoresis, a process in which a low-intensity electric field is used to transport the drug (fentanyl) across the skin and into the circulatory system. Ionsys is attached to the upper arm or chest and provides a 40-mcg dose of fentanyl over a 10-minute period when the patient activates the dosing button. The system is approved for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Ionsys is indicated only for use in hospitals and should not be used at home. According to Alza, patients should be titrated to an acceptable level of analgesia prior to using the Ionsys system. The company estimates distribution will begin sometime in 2007.
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