Healthcare Industry News:  Transdermal 

Biopharmaceuticals Drug Delivery Regulatory

 News Release - January 30, 2006

European Commission Approves IONSYS(TM) (Fentanyl HCl Iontophoretic Transdermal System)

First Needle-Free, Iontophoretic System for Acute Post-operative Pain

MOUNTAIN VIEW, Calif., Jan. 30 (HSMN NewsFeed) -- 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.

ALZA Corporation is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, Transdermal, implantable, and liposomal technologies. More than 30 products marketed in over 80 countries worldwide now incorporate ALZA's drug delivery technologies.

[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K are available online at http://www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.]


Source: ALZA Corp

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