Duragesic and Durogesic are the trade names of fentanyl transdermal therapeutic systems, and are used for moderate to severe pain relief.

Duragesic and Durogesic are the trade names of fentanyl transdermal therapeutic systems, and are used for moderate to severe pain relief. Since Duragesic/Durogesic release fentanyl, a potent opioid, slowly through the skin, one patch may provide 72 hours of pain relief. Though its initial onset after a patch has been applied is roughly (under normal conditions) 8-12 hours, thus Duragesic patches are often prescribed with another opioid (such as morphine sulfate) to handle breakthrough-pain.

Durogesic was first approved by the CBG in the Netherlands on 17 July 1995 as 25, 50, 75 and 100 痢/hour formulations, and on 27 October 2004 the 12 痢/hour formulations was approved as well. On Jan 28, 2005, the U.S. Food and Drug Administration approved first-time generic formulations of 25, 50, 75, and 100 痢/hour fentanyl transdermal systems (made by Mylan Technologies, Inc.; brand name Duragesic, made by Alza Corp.) The generic bioequivalent of Duragesic is available in 12, 25, 50, 75, and 100 痢 dosages, while the trade names Duragesic and Durogesic are available in 12.5, 25, 50, 75, and 100 痢 dosages. During the period of June 2002銺une 2003, Duragesic sales totaled over one billion dollars.

It is manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (both subsidiaries of Johnson & Johnson). Fentanyl, developed by Janssen Pharmaceutica.

Description of transdermal system
Duragesics system employs a form-fill-seal technology in which a drug-laden gel is sealed between an impermeable backing and a drug-permeable release liner.

Because of concerns for the high abuse factor of the gel filled Duragesic patches, Janssen-Cilag developed the Durogesic patch, a patch available in the same strengths as the Duragesic patches, but instead containing the Fentanyl in its plastic matrix. Because Durogesic does not contain its Fentanyl in a gel filled reservoir, but in its plastic matrix, it can not be cut open to remove the gel to be smoked or taken sublingually. In most of Europe, only Durogesic formulations are available because of stricter regulation of opioids.

Warnings
Since Duragesic and Durogesic are highly potent, there are many black box warnings in Duragesic's and Durogesic's prescribing information (PDF file). Additionally, due to the risk of serious adverse drug reactions, it is highly important that the patches be applied correctly and as prescribed.

Recalls
Janssen Pharmaceutica Products, L.P., initiated a series of Class II Recalls in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the American FDA.