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Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans® (Buprenorphine) Transdermal System CIII Published in The Journal of Pain
Date:9/23/2011

STAMFORD, Conn., Sept. 23, 2011 /PRNewswire/ -- Butrans® (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study published in the online, August issue of The Journal of Pain.

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"The publication of this data provides important information to healthcare professionals about the role of Butrans 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," 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 an 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 healthcare providers training, 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 depress
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SOURCE Purdue Pharma L.P.
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