IONSYS(TM)
ALZA Corporation's needle-free, patient-activated analgesic system

The ALZA Corporation’s IONSYS™ fentanyl iontophoretic transdermal system is the first needle-free, patient-activated analgesic system for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization. The FDA has approved IONSYS™.

IONSYS is the first product to incorporate the proprietary E-TRANS® iontophoretic transdermal drug delivery system developed by ALZA. E-TRANS utilizes iontophoresis — a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body. IONSYS securely adheres to the upper outer arm or chest, and provides patients an on-demand dose of fentanyl. Fentanyl is an opioid analgesic that has been used in the management of pain for more than 40 years.

Unlike other methods of administering pain medications after surgery such as intravenous patient-controlled analgesia (IV PCA) pumps, which tether patients to an IV pole and equipment, IONSYS is compact, self-contained and needle-free. When pain medication is needed, the patient double-clicks the dosing button, which delivers a pre-programmed, 40mcg dose of fentanyl through the skin. Each dose is delivered over a 10-minute period.

In January 2006, the European Commission approved the use of IONSYS in the 25 member states of the European Union. IONSYS will be marketed in the United States by Ortho-McNeil, Inc. and in the European Union by Janssen-Cilag companies. ALZA, Ortho-McNeil, Inc. and Janssen-Cilag are affiliates of Johnson & Johnson.

IONSYS is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization. Patients should be titrated to an acceptable level of analgesia before initiating treatment with IONSYS. IONSYS is not intended for home use and is, therefore, inappropriate for use in patients once they have been discharged from the hospital. It is not recommended for patients under the age of 18 years.

For safety information about the product please visit: http://www.alza.com/alza/pr_1148407686