Consumer goods firm Reckitt Benckiser Group Plc (RB.L,RBGPF.PK) announced Tuesday that its business Reckitt Benckiser Pharmaceuticals Inc., is voluntarily discontinuing the supply of Suboxone tablets for heroin treatment, due to increasing concerns with pediatric exposure.
Reckitt Benckiser's decision follows an analysis of data obtained 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 seen with Suboxone film. The rates for Suboxone tablets were 7.8 to 8.5 times greater depending on the study period.
Suboxone sublingual film is indicated for maintenance treatment of opioid dependence, also known as prescription opioid painkiller and heroin addiction, a growing epidemic in the U.S. Opioid dependence is a chronic and progressive medical condition caused in part by changes in chemistry of brain that can result from regular opioid drug use.
The company said today that it has notified the matter to the U.S. Food and Drug Administration, or FDA, on September 18. It expects to discontinue distribution of the tablets within the next six months, possibly sooner, depending on talks with the FDA.
The company also will ensure that patients currently taking Suboxone tablets will have sufficient time to transition to Suboxone Film to minimize any risk to the continuity of their treatment.
Reckitt Benckiser estimates that since the U.S. launch of Suboxone in 2003, over three million Americans with opioid dependence have been treated with Suboxone tablets and Suboxone film.
Last month end, Reckitt Benckiser Pharmaceuticals announced that the FDA granted approval for 4 mg dose and 12 mg dose of Suboxone sublingual film. The company had developed the 4 mg and 12 mg strengths in an ongoing effort to help mitigate the risk of unintentional multi-dose pediatric exposure.
In London, Reckitt Benckiser shares are currently trading at 3,607 pence, down 31 pence or 0.85 percent, on a volume of 1.04 million shares.
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