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Published on 5/23/2006 in the Prospect News Biotech Daily.

ALZA gets FDA approval for Ionsys fentanyl transdermal system

By Elaine Rigoli

Tampa, Fla., May 23 - The Food and Drug Administration has approved ALZA's Ionsys fentanyl iontophoretic transdermal system, the first needle-free, patient-activated analgesic system indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization.

ALZA said Ionsys incorporates the E-Trans iontophoretic transdermal drug-delivery system, which uses iontophoresis - a process in which a low-intensity electric field is used to rapidly transport fentanyl across the skin and into the circulatory system of the body.

ALZA said Ionsys adheres to the upper outer arm or chest and provides patients an on-demand dose of fentanyl, an opioid analgesic that has been used in the management of pain for more than 40 years.

In January, 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.

Mountain View, Calif.-based ALZA develops technology platforms, including oral, transdermal, implantable and liposomal technologies.


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