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Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Response to Citizen's Petition
Date:2/25/2013

helps increase retention in treatment by managing withdrawal symptoms and reducing cravings. SUBOXONE Film also includes naloxone, an opioid antagonist, to help minimize its attractiveness for deliberate parenteral misuse.  When SUBOXONE Film is taken as prescribed (i.e. dissolved under the tongue) the naloxone has no effect.  SUBOXONE Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

Only physicians certified under the Drug Addiction Treatment Act (DATA) 2000 can prescribe SUBOXONE. As part of the U.S. FDA requirements to ensure the benefits of treatment with SUBOXONE Film outweigh potential risks particularly risks of accidental overdose, misuse and abuse, the company has implemented a Risk Evaluation and Mitigation Strategy program as a follow-on to the RiskMAP.

SUBOXONE patients can visit SUBOXONE.com or call 866-973-HERE (866-973-4373), and providers can call 877-SUBOXONE (877-782-6966), for more information.

About Opioid Dependence
Opioid dependence is a chronic medical condition caused in part by the changes in the chemistry of the brain that can result from regular opioid drug use.  The World Health Organization and the National Institute on Drug Abuse define opioid dependence as a chronic brain disease.

Approximately two million Americans were dependent on prescription opioid painkillers in 2010.  In the same year, nearly 400,000 people abused or were dependent on heroin.  The Centers for Disease Control and Prevention in November 2011 issued a report that showed prescription opioid painkiller overdose has reached epidemic levels in the United States.  Furthermore, taking prescription opioid painkillers without a medical need increased 75 percent from 2002 to 2010.  A total of 12 million Americans reported misusing prescription opioid painkillers in 2010.  Men and individ
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SOURCE Reckitt Benckiser Pharmaceuticals Inc.
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