FDA Grants Approval for Reckitt Benckiser Pharmaceuticals Inc.'s Suboxone Sublingual Film
8/20/2012 7:58:40 AM
RICHMOND, Va., Aug. 20, 2012 /PRNewswire/ -- Reckitt Benckiser Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) approval of the 4 mg and 12 mg doses of Suboxone® (buprenorphine and naloxone) sublingual film. Suboxone® sublingual film is indicated for maintenance treatment of opioid dependence, also known as prescription opioid painkiller and heroin addiction, a growing epidemic in the United States. Reckitt Benckiser Pharmaceuticals Inc. developed the 4 mg and 12 mg strengths in an ongoing effort to help mitigate the risk of unintentional multi-dose pediatric exposure, which is a major public health concern associated with medications. Having the individually wrapped, unit-dose packaging of Suboxone® sublingual film in more dosage choices provides healthcare professionals with more flexible, customizable treatment options, and may help reduce the risk of children accessing inappropriately stored medication.
"Opioid dependence affects millions of Americans from all walks of life and socioeconomic levels, with the number growing each year," said Richard Simkin, President North America, Reckitt Benckiser Pharmaceuticals Inc. "As the market leader and committed partner of care, we developed Suboxone® sublingual film and the portfolio of dosage strengths to respond to critical public health issues: helping fulfill treatment needs with a product that is both effective and individualized, and reducing the risk of pediatric exposure."
Suboxone® sublingual 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® sublingual 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® sublingual film is best delivered in conjunction with counseling and psychosocial support. The new 4 mg and 12 mg dosage strengths of Suboxone® sublingual film will be available later this year.
About Suboxone® Sublingual Film (C-III)
Suboxone® sublingual film (C-III) was approved by the FDA on August 30, 2010, and combines buprenorphine and naloxone in a 4:1 ratio of 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg dosage formulations, respectively. Suboxone® sublingual film's main active ingredient is buprenorphine, a partial opioid agonist that strongly binds to the opioid receptors in the brain and blocks other opioids from attaching. Buprenorphine helps reduce opioid use and increases retention in treatment by managing withdrawal symptoms and reducing cravings. Suboxone® sublingual film also includes naloxone, an opioid antagonist, to minimize its attractiveness for deliberate misuse. When Suboxone® sublingual film is taken as prescribed dissolved under the tongue the naloxone has no effect.
Since the U.S. launch of Suboxone in early 2003, nearly three million Americans with opioid dependence have been treated. Only physicians certified under the Drug Addiction Treatment Act 2000 can prescribe Suboxone®. As part of the FDA requirements to ensure the benefits of treatment with Suboxone® sublingual film outweigh potential risks particularly risks of accidental overdose, misuse and abuse the company has a implemented a Risk Evaluation and Mitigation Strategy program as a follow-on to the RiskMap.
About Opioid Dependence
Opioid dependence is a chronic and progressive medical condition caused in part by the changes in the chemistry of the brain that can result from regular opioid drug use. Dependence on opioids has been defined as a chronic (long-term) brain disease by the World Health Organization and the National Institute on Drug Abuse. Once opioid dependence develops, it is a chronic condition that left untreated can be fatal.
Approximately two million Americans abused or 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.
Important Safety Information
Suboxone® (buprenorphine and naloxone) sublingual film (C-III) 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.
Suboxone® sublingual film should not be used by patients hypersensitive to buprenorphine or naloxone.
Suboxone® sublingual film can be abused in a manner 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® 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, tranquilisers, 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 in pregnant women or during breast-feeding should be only 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 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.
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.
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.