The FDA has approved Purdue’s Butrans (buprenorphine) Transdermal System for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. This approval was based on data from two clinical studies that enrolled adult patients with moderate to severe chronic low back pain and included open-label titration periods followed by randomized, double-blind, 12-week study periods. Study 1, a placebo-controlled trial, enrolled opioid naive patients who were suboptimally responsive to their non-opioid therapy. In this study, 53% of the patients receiving Butrans were able to titrate to a tolerable and effective dose. Study 2 used a low dose Butrans control group (Butrans 5mcg/hour) and enrolled patients who had been previously treated with a variety of opioids in conjunction with or without non-opioid therapies. In this study, 57% patients were able to titrate to and tolerate the adverse effects of Butrans 20mcg/hour.

Butrans is a Schedule III controlled substance. It will be available in early 2011 in 5microgram/hour, 10microgram/hour, and 20microgram/hour dosage strength patches that release medication continuously for seven days.

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