been previously treated with a variety of opioids in conjunction with or without non-opioid therapies. In this study, 57 percent of the patients who entered the open-label titration period were able to titrate to and tolerate the adverse effects of Butrans 20 mcg/hour and were randomized into a 12-week double-blind treatment phase. Twelve percent of patients discontinued due to an adverse event, and 21 percent discontinued due to lack of a therapeutic effect during the open-label titration period. During the double-blind treatment in the Butrans 20 mcg/hour group, 11 percent discontinued early due to lack of efficacy and 13 percent due to adverse events; in the Butrans 5 mcg/hour group, 24 percent discontinued early due to lack of efficacy and 6 percent due to adverse events.
Adverse Event InformationThe most common adverse events (greater than or equal to 5%) reported by patients treated with Butrans in the clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash. The most frequently occurring application site skin reactions were application site pruritus, erythema, rash and irritation. In rare cases, severe application site skin reactions with signs of marked inflammation including "burn," "discharge," and "vesicles" have occurred.
The Full Prescribing Information for Butrans is available at www.purduepharma.com/PI/prescription/ButransPI.pdf. Additional information, including a Medication Guide, is available at www.Butrans.com. Working with the FDA, Purdue has also developed a Risk Evaluation and Mitigation Strategy (REMS) for Butrans. The Butrans REMS will include a Medication Guide, Elements to Assure Safe Use, such as healthcare providers training, and a timetable Page: 1 2 3 4 5 6 Related medicine technology :1
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