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SOURCE Purdue Pharma L.P.
STAMFORD, Conn., Sept. 24, 2013 /PRNewswire/ -- Purdue Pharma L.P. announced that the U.S. Food and Drug Administration (FDA) approved a new 15 mcg/hour dosage strength of Butrans® (buprenorphine) Transdermal System CIII, which will provide an additional titration option for healthcare professionals. Four strengths of Butrans will now be available: 5, 10, 15 and 20 mcg/hour. Purdue expects to launch Butrans 15 mcg/hour commercially in the U.S. in October 2013.
Butrans is indicated for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Limitations of Use: Butrans is not for use: as an as-needed (prn) analgesic; for pain that is mild or not expected to persist for an extended period of time; for acute pain; for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.
Butrans is the first transdermal system that delivers a continuous release of buprenorphine for seven days. The active ingredient in Butrans Transdermal System is buprenorphine, a partial agonist at mu opioid receptor, and a Schedule III controlled substance.
"The approval of Butrans 15 mcg/hour dosage offers healthcare professionals added flexibility when using Butrans for the management of moderate to severe chronic pain," said Gary Stiles, M.D., Senior Vice President, Research and Development, Purdue Pharma L.P. "The new strength provides another option when adjusting the dose to obtain an appropriate balance between adequate pain relief and opioid-related adverse reactions."
"The approval of the 15 mcg/hour patch of Butrans provides healthcare professionals the ability to individualize the dose of Butrans to the specific needs of patients," said Jeffrey A. Gudin, M.D., Director of The Pain Management and Wellness Center at Englewood Hospital and Medical Center.
The Full Prescribing Information for Butrans contains the following Boxed Warning:
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE
Life-Threatening Respiratory Depression
Parentheses refer to sections in the Full Prescribing Information.
Butrans is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Purdue supports prescriber and patient education as part of a comprehensive approach to address misuse, abuse and diversion of opioid pain medicines, while ensuring that these medications remain accessible for patients with moderate to severe, chronic pain when appropriate. Information on the shared REMS is available at www.ER-LA-opioidREMS.com.
Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
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