US FDA approves Alza's IONSYS

The US Food and Drug Administration has approved Alza Corp's IONSYS (fentanyl iontophoretic transdermal system), a first needle-free, patient-activated analgesic system. IONSYS is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization.

IONSYS is the first and only product to incorporate the proprietary E-TRANS iontophoretic transdermal drug delivery system developed by Alza. This system utilizes iontophoresis - a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body, says the company. IONSYS securely adheres to the upper outer arm or chest and provides patients an on-demand dose of fentanyl. Fentanyl is an opioid analgesic that has been used in the management of pain for more than 40 years, notes Alza.

In January 2006, the European Commission approved the use of IONSYS in the 25 member states of the European Union. It will be marketed in the USA by Ortho-McNeil and in the EU by Janssen-Cilag companies. Alza says it is finalizing the manufacturing processes and scale up, along with the US Risk Minimization Action Plan, prior to distribution of The product, which is expected in 2007. Alza, Ortho-McNeil and Janssen-Cilag are all affiliates of US health care major Johnson & Johnson.