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Reckitt Benckiser to Discontinue Suboxone Tablets in U.S.

Concerns with pediatric exposure cause switch to sublingual film (Sept. 25)

In response to queries from stakeholders, Reckitt Benckiser Pharmaceuticals Inc. confirmed on September 25 that it has notified the FDA that the company is voluntarily discontinuing the supply of Suboxone (buprenorphine and naloxone) sublingual tablets in the U.S. because of increasing concerns with pediatric exposure.

The company received an analysis of data from the U.S. Poison Control Centers on September 15 that found consistently and significantly higher rates of accidental unsupervised pediatric exposure with Suboxone tablets than with Suboxone sublingual film. The rates of accidental pediatric exposure for Suboxone tablets were 7.8 to 8.5 times greater depending on the study period.

While the data do not identify the root cause of these findings, the child-resistant, unit-dose packaging of Suboxone film is believed to be one of the key contributing factors to the decrease in exposure rates compared with Suboxone tablets, which are distributed in a multidose bottle containing 30 tablets, since the active ingredients of both products are the same.

Reckitt Benckiser is working with the FDA and the broader healthcare community to ensure that patients currently taking Suboxone tablets have sufficient time and notification to appropriately transition to the same active ingredients with Suboxone film to minimize any risk to the continuity of their treatment.

The company anticipates that distribution of Suboxone tablets will be discontinued within the next 6 months or possibly sooner, depending on discussions with the FDA.

The pediatric exposure safety issue is not related to the active ingredients found in both Suboxone tablets and Suboxone film. The company encourages patients currently taking Suboxone tablets to continue with their treatment and to consult their physicians about how to transition to Suboxone film. Suboxone film is covered by most insurance plans, Medicare, and Medicaid. In addition, patients can access a savings program at or from their physician to offset out-of-pocket costs associated with their medication.

Since the U.S. launch of Suboxone in 2003, the company estimates that more than 3 million Americans with opioid dependence have been treated with the tablet and film formulations of the drug.

For more information, visit the Reckitt Benckiser Web site.

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