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European Commission Approves Fentanyl HCl Iontophoretic Transdermal System
Posted: January 30, 2006
The European Commission has granted marketing authorization in the 25 member states of the European Union for the use of IONSYS (Fentanyl hydrochloride (HCl) Iontophoretic Transdermal System (ITS) 40 mcg/dose). According to Johnson & Johnson, the system is the first needle-free, iontophoretic, patient-controlled transdermal system to receive marketing authorization, and is indicated for the management of acute moderate to severe post-operative pain, for use by adults, in a hospital setting only.
The non-invasive, self-contained and pre-programmed analgesic system is designed to adhere to a patient's upper arm or chest and uses a low level electrical current to deliver the medication directly through the skin and into the bloodstream with the push of a button. It will be marketed in the European Union by Janssen-Cilag companies, which are affiliates of Johnson & Johnson. ALZA Corporation, the Johnson & Johnson affiliate that developed the system, reportedly is working on the manufacturing processes and scale up, and launch is expected in 2007. The treatment is currently under review by the US Food and Drug Administration, and upon approval, Ortho-McNeil Inc. will market the product in the United States.