Reckitt Benckiser Pharmaceuticals Inc. (RBGPY) recently announced that it has received approval for two new dosages (4mg and 12 mg) of Suboxone (buprenorphine and naloxone) sublingual film from the US Food and Drug Administration (FDA). Suboxone is approved for the treatment of opioid dependence, which is also known as prescription opioid or heroin addiction.
Reckitt has developed the new dosages in order to minimize risks associated with multi-dose pediatric exposure. The new dosages are expected to be available by the end of 2012.
Reckitt’s Suboxone sublingual film (C III) containing buprenorphine and naloxone in a ratio of 4:1 received FDA approval in August 2010. The formulation is available in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg dosages.
We note that Suboxone, which was launched by Reckitt in 2003, has treated approximately three million Americans who were diagnosed with opioid dependence. To ensure safety and efficacy of the treatment with Suboxone sublingual film, Reckitt has implemented a Risk Evaluation and Mitigation Strategy (REMS) as per the requirements of the FDA. Suboxone can be prescribed only by physicians certified under the Drug Addiction Treatment Act 2000.
Our Take
We believe that the launch of the new dosages of Suboxone sublingual film will further help in the treatment of opioid dependence, which is considered a widespread disease in the US. In 2010, nearly two million Americans and 400,000 people worldwide were dependent on opioid painkillers and heroin, respectively. A report issued by The Centers for Disease Control and Prevention in November 2011 showed that opioid dependence overdose reached epidemic levels in the US.
Treatment with Suboxone sublingual film as an adjunct to counseling and psychosocial support is believed to deliver best results against the disease. Reckitt Benckiser currently carries a Zacks #4 Rank (‘Sell’ rating) in the short run.
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