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FDA approves Reckitt Benckiser's Suboxone sublingual film for treatment of opioid dependence
Tuesday, August 31 2010 | Comments
What's This?
Reckitt Benckiser Pharmaceuticals Inc. received approval from the Food and Drug Administration to market Suboxone (buprenorphine hydrochloride/naloxone hydrochloride dihydrate) sublingual film for the treatment of opioid dependence.Suboxone sublingual film is indicated for the maintenance treatment of opioid dependence and should be used in a comprehensive treatment strategy that includes counseling and psychosocial support.
The product was developed through an exclusive agreement with MonoSol Rx LLC, which owns the PharmFilm technology used to deliver the opioid dependence treatment in a fast-dissolving sublingual film. Based on the worldwide agreement, MonoSol Rx will manufacture the sublingual film product and Reckitt Benckiser will be responsible for marketing it.
Suboxone sublingual film is expected to be available starting in early October and will be available in the same dosage strengths as Reckitt Benckiser's Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) sublingual tablets, which were approved in 2002.
Reckitt Benckiser noted that, in accordance with FDA requirements, a risk evaluation and mitigation strategy program is being implemented for Suboxone sublingual film to ensure that the benefits of Suboxone therapy outweigh the potential risks, particularly risks of accidental overdose, misuse and abuse.
In March, Reckitt Benckiser Group Plc bought back the sales and marketing rights to Suboxone from Merck & Co. Inc. Reckitt Benckiser already controlled the sales and marketing of Suboxone and two other buprenorphine-based products in the United States and Australia; with the March transaction, the firm regained the rights in a number of countries in Europe and the rest of the world on July 1. The rights Merck owned were originally scheduled to revert to Reckitt Benckiser in 2012.
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