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Title: European Commission Approves Ionsys (Fentanyl HCl Iontophoretic Transdermal System) for Acute Post-operative Pain

"European Commission Approves Ionsys (Fentanyl HCl Iontophoretic Transdermal System) for Acute Post-operative Pain"

MOUNTAIN VIEW, CA -- January 30, 2006 -- The European Commission has granted marketing authorization in the 25 member states of the European Union for the use of Ionsys(TM) (fentanyl hydrochloride (HCl) iontophoretic transdermal system (ITS) 40 mcg/dose). Ionsys 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. Ionsys is a compact, non-invasive, self-contained and pre-programmed analgesic system. Designed to adhere to a patient's upper arm or chest, the system uses a low level electrical current to deliver the medication directly through the skin and into the bloodstream with the push of a button. Ionsys 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 Ionsys, is working on the manufacturing processes and scale up, and launch is expected in 2007. Ionsys is currently under review by the United States Food and Drug Administration, and upon approval, Ortho-McNeil, Inc. will market the product in the U.S. The active drug, fentanyl, can cause life-threatening respiratory depression. Fentanyl is an opioid agonist and a Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine and oxycodone. Fentanyl can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered in situations where the healthcare professional is concerned about an increased risk of misuse, abuse or diversion. The most common side effects associated with Ionsys in clinical trials were nausea, vomiting, headache and pruritus. These were mostly of mild-to-moderate severity. SOURCE: ALZA Corporation

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