Study Finds IONSYS™, A New Needle-Free System For Management Of Acute Postoperative Pain, Requires Less Staff Compared To IV PCA Treatment

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 10 Mar 2008 - 0:00 PDT

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New data released at the World Congress of Anaesthesiologists (WCA) show that IONSYS™ (fentanyl iontophoretic transdermal system - ITS) may save hospital staff time compared to Intravenous Patient Controlled Analgesia (IV PCA).

Fentanyl ITS, a new innovative, needle-free system indicated for the management of acute postoperative pain in a hospital setting, was launched in European countries starting in January this year. Fentanyl ITS has been shown to be as effective as IV PCA morphine for the management of acute postoperative pain.1

The presentation at the WCA included data from two separate studies conducted in Germany and the United States. Study one showed that Fentanyl ITS requires only a third of the hospital staff time needed for administration of IV PCA (21.4 minutes vs 69.5 minutes respectively). In addition, hospital staff took 64 steps to use Fentanyl ITS versus 146 steps for IV PCA. The labour-associated process cost per patient per course of therapy was calculated to be 23.90€ for Fentanyl ITS compared to 63.19€ for IV PCA.

In a second study, hospital staff took 46 steps to use fentanyl ITS compared to between 70 and 104 steps for IV PCA at different hospitals.

These results suggest that Fentanyl ITS is more time efficient and convenient for hospital staff, and could thus free-up time for other important tasks in the hospital.

Additional study presented at the WCA: efficacy and safety by surgery type

Another study, presented at the WCA on 3 March, compared the efficacy and safety data from four large active comparator trials. The investigators concluded that Fentanyl ITS is a viable alternative to morphine IV PCA for postoperative pain management across many types of surgery. These data further support the results of a study published in the November/December 2007 issue of Pain Medicine in which Fentanyl ITS was rated comparably as a method of pain control to a standard regimen of morphine IV PCA following abdominal and pelvic surgeries.3

Managing postoperative pain

Research indicates there is a significant unmet need for new therapeutic options to manage postoperative pain. In a survey of European anaesthesiologists, 55 percent indicated that they were dissatisfied or very dissatisfied with postoperative pain management options on surgical wards.4

About IONSYS™ (fentanyl iontophoretic transdermal system)

IONSYS™ is a preprogrammed system designed to provide a safe, easy-to-use method of pain control for hospitalised patients and their healthcare professionals. 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 and self-contained. As a patient activated system it does not require needles which eliminates the risk of needle-stick injuries and infection due to analgesic administration with IV PCA.

IONSYS™ 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, a virtually imperceptible low-intensity electrical field is used to rapidly transport fentanyl through the skin and into the bloodstream in a technologically advanced process called iontophoresis. 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, vomiting, headache and pruritis.5

IONSYS™ is the first product to incorporate the proprietary iontophoretic transdermal drug delivery system developed by ALZA Corporation, an affiliate of Janssen-Cilag.

The regulatory status of this product may vary from country to country.

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). More information can be found at http://www.janssen-cilag.com.

References:

1 Viscusi, E.R. et al Patient Controlled Transdermal Fentanyl Hydrochloride vs. Intravenous Morphine Pump for Postoperative Pain. JAMA, March 17th 2004 Vol. 291, No. 11.

2 Pain: Current Understanding of Assessment, Management and Treatments. Developed by NPC as part of a collaborative project with JCHO. December 2001.

3 Minkowitz HS, Rathmell JP, Vallow S, Gargiulo K, Damaraju CV, Hewitt DJ. Efficacy and safety of the fentanyl ontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) with morphine for pain management following abdominal or pelvic surgery Pain Med. 2007;8(8):657-668.

4 Rawal and Allvin. Acute Pain Services in Europe: A 17 Nation Survey of 105 Hospitals. European Journal of Anaesthesiology, May 1998 Vol. 15.

5 IONSYS™ Summary of Product Characteristics.