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.