RICHMOND, Va. — The Food and Drug Administration has approved a drug made by Reckitt Benckiser Pharmaceuticals for treating addiction to opioid drugs, the drug maker said.
Reckitt Benckiser announced the approval of Suboxone (buprenorphine and naloxone) sublingual film in the 4 mg and 12 mg strengths, used for the maintenance treatment of dependence on prescription opioid painkillers and heroin. Addiction to opioid drugs is a growing epidemic in the United States, the company said.
"Opioid dependence affects millions of Americans from all walks of life and socioeconomic levels, with the number growing each year," Reckitt Benckiser president for North America Richard Simkin said. "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."