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Butrans® (Buprenorphine) Transdermal System CIII Pivotal Phase 3 Data Published in the Journal of Pain and Symptom Management
Date:10/26/2011

STAMFORD, Conn., Oct. 26, 2011 /PRNewswire/ -- A pivotal Phase 3 study of Butrans® (buprenorphine) Transdermal System CIII in opioid-naive patients with moderate-to-severe chronic low back pain demonstrated significantly lower "average pain over the last 24 hours" scores compared to placebo at the end of a 12-week, randomized, double-blind phase, in a study published in the online version of the September issue of the Journal of Pain and Symptom Management.

"These data are important in understanding the role of Butrans for opioid-naive patients with moderate-to-severe chronic pain requiring a continuous, around-the-clock opioid analgesic for an extended period of time," said Deborah Steiner, MD, MS, medical director at Purdue Pharma L.P.

The Butrans Transdermal System, approved by the U.S. Food and Drug Administration (FDA) in June 2010, is indicated 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.  Butrans is the first transdermal system approved in the United States that delivers continuous release of the active ingredient, buprenorphine, for seven days.

Butrans is a Schedule III opioid prescription medication and can be abused in a manner similar to other opioid agonists, legal or illicit.  Working with the FDA, Purdue Pharma L.P. has developed a Risk Evaluation and Mitigation Strategy (REMS) for Butrans that includes a Medication Guide, Elements to Assure Safe Use, such as a healthcare provider training guide, and a timetable for submitting assessments of the REMS.  This information is available at www.Butransrems.com.

Butrans is contraindicated in patients who have significant respiratory depression, severe bronchial asthma, who have or are suspected o
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SOURCE Purdue Pharma L.P.
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