IONSYS, The Highly Innovative Needle-Free System For The Management Of Acute Post-Pperative Pain, Available In Germany, The UK And Ireland

Main Category: Pain / Anesthetics
Article Date: 15 Jan 2008 - 1:00 PDT

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Janssen-Cilag International NV announced that IONSYS (fentanyl iontophoretic transdermal system), a new innovative, needle-free system indicated for the management of acute post-operative pain in a hospital setting, will become available in Germany, the UK and Ireland this week. These countries represent the first markets to launch this novel product, and additional launches in other European countries are planned for the coming months.

As a patient activated system, the fentanyl iontophoretic transdermal system does not require needles, pumps, catheters or intravenous (IV) pump stands in the management of post-operative pain. Being needle-free, this treatment eliminates the risk of needle-stick injuries and infection due to analgesic administration with Intravenous Patient Controlled Analgesia (IV PCA). This system has the potential to make the administration of post-operative pain management a less time consuming task for healthcare professionals and less intrusive for patients.

The fentanyl iontophoretic transdermal system is a compact, self-contained, preprogrammed system designed to simplify the delivery of post-operative pain relief for hospitalised patients and their healthcare professionals. It is small and lightweight and has an adhesive backing that securely adheres to the patient's upper outer arm or chest. After the patient presses a button on the system, IONSYS uses a virtually imperceptible low-intensity electrical field to rapidly transport fentanyl through the skin and into the bloodstream in a technologically advanced process called iontophoresis.

Research indicates there is a significant unmet need for new therapeutic options to manage post-operative pain. A survey of European anaesthesiologists indicated that 55% were dissatisfied or very dissatisfied with post-operative pain management options on surgical wards1.

In addition to affecting patients' lives, post-operative pain places considerable economic burden on healthcare providers, caregivers and healthcare professionals2.

The European Commission granted marketing authorisation for IONSYS throughout the EU based on the findings of a comprehensive clinical trial programme. In November 2007, a Type II variation was approved by the Commission, in reference to a change in the product packaging and a change in the package leaflet. The fentanyl iontophoretic transdermal system has been demonstrated to be as effective as IV PCA morphine for the management of acute post-operative pain3.

About IONSYS (fentanyl iontophoretic transdermal system)

IONSYS is the first product to incorporate the proprietary iontophoretic transdermal drug delivery system developed by ALZA Corporation, an affiliate of Janssen-Cilag. It has been carefully designed to provide a safe, easy-to-use method of pain control. The system is pre-programmed to deliver up to six 40-mcg doses of fentanyl per hour with a maximum of 80 doses during 24 hours. The unique design of the fentanyl iontophoretic transdermal system reduces the potential for abuse; it will shut down automatically after the maximum number of doses has been administered or the 24-hour period has ended, and is designed for safe disposal.

IONSYS has a safety and tolerability profile consistent with that of other opioids. As with other opioids, the most commonly reported adverse events in all controlled studies were nausea, fever, vomiting and pruritis4.

ALZA and Janssen-Cilag are part of the Johnson & Johnson family of companies.

(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 Janssen-Cilag'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 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov or on request from Johnson & Johnson. Janssen-Cilag does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

The Janssen-Cilag companies have a long track record in developing and marketing treatments for a wide variety of conditions. Leading products include JURNISTA (pain management), CONCERTA (ADHD), EPREX (anaemia), SPORANOX® (fungal infections), VELCADE® (multiple myeloma), PARIET (gastroenterology), TOPAMAX (epilepsy), REMINYL (Alzheimer's disease), RISPERDAL (schizophrenia, acute bipolar mania, behavioural psychological symptoms of dementia, disruptive behaviour disorders, autism) and RISPERDAL CONSTA™ (schizophrenia).

Janssen-Cilag