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Published on 1/30/2006 in the Prospect News Biotech Daily.

Johnson & Johnson's Ionsys analgesic system approved by European Commission

By Angela McDaniels

Seattle, Jan. 30 - Johnson & Johnson Inc. said the European Commission has granted marketing authorization for the use of Ionsys (Fentanyl hydrochloride Iontophoretic Transdermal System) 40 mcg/dose, a non-invasive, self-contained and pre-programmed analgesic system.

Ionsys is the first needle-free, iontophoretic, patient-controlled transdermal system to receive marketing authorization in the European Union, according to a company news release, and is indicated for the management of acute moderate to severe post-operative pain for use by adults in a hospital setting.

Ionsys is designed to adhere to a patient's upper arm or chest and use a low-level electrical current to deliver 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 Corp., the Johnson & Johnson affiliate that developed Ionsys, is working on the manufacturing processes and scale up and launch is expected in 2007, the company said.

Ionsys is under review by the Food and Drug Administration, and upon approval, Ortho-McNeil Inc. will market the product in the United States.

New Brunswick, N.J.-based Johnson & Johnson is a manufacturer and marketer of health care products. Affiliate ALZA is based in Mountain View, Calif., and develops drug delivery technologies.


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