Duragesic

Duragesic (IPA: [ˌdɚə'dʒiʒɪk], Durogesic in Europe) is the trade name of a fentanyl transdermal therapeutic system, and is used for moderate to severe pain relief. Since Duragesic releases fentanyl, a potent opioid, slowly through the skin, one patch may provide 72 hours of pain relief.

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On Jan 28 2005, the U.S. Food and Drug Administration approved first-time generic formulations of 25, 50, 75, and 100 µg/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 µg dosages, while the trade name Duragesic is available in 12.5, 25, 50, 75, and 100 µg dosages. During the period of June 2002–June 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

The 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.

Durogesic D-Trans, available in some European countries, as well as in the U.S. generic version of Duragesic consists of a thinner, solid single-layer plastic patch with the fentanyl matrix-bonded in an adhesive layer.

Warnings

Since Duragesic is highly potent, there are many black box warnings in Duragesic'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 FDA.