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Reckitt Benckiser Pharmaceuticals Inc. Disappointed Over FDA Denial  
2/25/2013 7:13:25 AM

RICHMOND, Va., Feb. 25, 2013 /PRNewswire/ -- Reckitt Benckiser Pharmaceuticals Inc. (RBP) announces that the U.S. Food and Drug Administration (FDA) has denied a Citizen's Petition filed by the Company. In the Citizen's Petition, RBP presented a new evaluation of pediatric exposure data and recommended that the FDA adopt more stringent packaging standards and increased educational interventions to help reduce the number of children exposed to buprenorphine-containing products used to treat opioid dependence. The FDA concluded that the safety data presented by RBP did not warrant these additional measures, deciding instead that existing labeling and safety programs were sufficient.

RBP is disappointed with the decision but will continue to work with the FDA on safety enhancements. RBP remains committed to maintaining its own high level standards for safety, including the use of child-resistant, unit-dose packaging for its buprenorphine-based opioid dependence treatment products. It will therefore carry on with the decision to discontinue the sale and cease distribution of SUBOXONE® Tablets (buprenorphine and naloxone) Sublingual (CIII) in the United States as of March 18, 2013, in light of the analysis evidencing an increased risk of pediatric exposure.

"As a pioneer in opioid dependence treatment, Reckitt Benckiser Pharmaceuticals Inc. strongly believes that child-resistant, unit-dose packaging and increased educational interventions are in the best interest of public health and safety, and we encourage other manufacturers to proactively implement these additional safeguards," says Tim Baxter, M.D., Global Medical Director, Reckitt Benckiser Pharmaceuticals Inc.

The communication from the FDA also informed RBP that two unnamed manufacturers have now received approval to produce generic SUBOXONE Tablets. The details of these manufacturers' proposed safety programs have not been provided.

RBP is a pioneer in the development of innovative prescription treatments for the chronic disease of addiction and introduced SUBOXONE Film (buprenorphine and naloxone) Sublingual (CIII) in 2010 as a next generation product with enhanced features, including child-resistant, unit-dose packaging, in response to patient and provider feedback and reports of misuse, abuse, diversion and pediatric exposure associated with SUBOXONE Tablets. RBP remains confident in the value and benefits of SUBOXONE Film as the product offers a significant advancement in formulation and product technology.

About SUBOXONE Film
Since the U.S. launch of SUBOXONE (buprenorphine and naloxone) in 2003, it is estimated that over three million Americans with opioid dependence have been treated with the active ingredients contained in SUBOXONE Film buprenorphine and naloxone.

SUBOXONE Film is an office-based treatment that allows patients to be discreetly treated for opioid dependence in the privacy of a physician's office. Because SUBOXONE Film is approved for at-home use, people living with opioid dependence can continue their daily lives while under a physician's care similar to other chronic diseases, such as diabetes, asthma or hypertension. Treatment with SUBOXONE Film is best delivered in conjunction with counseling and psychosocial support.

SUBOXONE Film was initially approved by the U.S. FDA on August 30, 2010, and combines buprenorphine and naloxone in a 4:1 ratio. SUBOXONE Film comes in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg dosage formulations, all of which are currently available in pharmacies.

SUBOXONE Film's main active ingredient is buprenorphine, a partial opioid agonist that strongly binds to the opioid receptors in the brain and dose-dependently blocks other opioids from attaching. Buprenorphine helps reduce opioid use and 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 individuals ages 26-49 saw the largest increase in nonmedical use of prescription opioid painkillers, taking the drugs 200 or more days a year.

Selected Safety Information
SUBOXONE (buprenorphine and naloxone) Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Indication
SUBOXONE Sublingual Film is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

Important Safety Information
SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

SUBOXONE (buprenorphine and naloxone) Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported.

Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk.

Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list at www.suboxone.com/pdfs/SuboxonePI.pdf.

To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Reckitt Benckiser Pharmaceuticals Inc.
Reckitt Benckiser Pharmaceuticals Inc. is a specialty pharmaceutical company committed to expanding education and access to medical therapies for patients suffering from the chronic, relapsing brain disease of opioid dependence. The company manufactures and markets medications that, in conjunction with counseling and psychosocial support, treat opioid dependence. Reckitt Benckiser Pharmaceuticals Inc. is a wholly owned subsidiary of Reckitt Benckiser Group plc, a global company publicly traded on the UK stock exchange.

SOURCE Reckitt Benckiser Pharmaceuticals Inc.


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