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Duragesic (or Durogesic in Europe) is the trade name of a fentanyl transdermal therapeutic system manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (a subsidiary of Johnson & Johnson). Fentanyl is a potent opioid, and is used for moderate to severe pain relief. Since Duragesic releases fentanyl slowly through the skin, one patch may provide 72 hours of pain relief. On Jan. 28, 2005 the FDA 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 25, 50, 75, and 100 mcg dosages, while the trade name Duragesic is available in 12.5, 25, 50, 75, and 100 mcg dosages. During the period of June 2002 - June 2003, Duragesic sales totaled over one billion dollars.
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 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. | ||||||||
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