Reckitt Benckiser Pharma to voluntarily discontinue Suboxone tablet supply in USA

In response to a number of queries from stakeholders, the pharmaceutical unit of conglomerate Reckitt Benckiser (LSE: RB) confirms that it notified the US Food and Drug Administration on September 18 that the company is voluntarily discontinuing the supply of its best-selling opioid dependency product Suboxone (buprenorphine and naloxone sublingual tablets [CIII]) in the USA due to increasing concerns with pediatric exposure.

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

While the data do not isolate the root cause of these findings, the unique child resistant, unit-dose packaging of the next generation Suboxone Film is believed to be one of the key contributing factors to the decrease in exposure rates compared to Suboxone Tablets that are distributed in a multi-dose bottle containing 30 tablets, since the active ingredients of both products are the same. Other factors may include Reckitt Benckiser Pharmaceuticals' community and health care professional educational initiatives in addition to the company's Risk Evaluation and Mitigation Strategy program.