Singapore: The US FDA has denied a Citizen's Petition filed by Reckitt Benckiser Pharma (RBP), which presented a new evaluation of pediatric exposure data. The petition recommended that the FDA adopt more stringent packaging standards and increase educational interventions to help reduce the number of children that are exposed to buprenorphine-containing products, which are used to treat opioid dependence.

The FDA concluded that the safety data presented by the firm did not warrant these additional measures and concluded that the existing labeling and safety programs were sufficient. The communication from the FDA also informed RBP that two unnamed manufacturers have now received approval to produce generic Suboxone Tablets (RBP's buprenorphine and naloxone containing drug). The details of these manufacturers' proposed safety programs have not been provided.

RBP highlighted that it is disappointed with the decision but will continue to work with the FDA on safety enhancements. Moreover, RBP will carry on with the decision to discontinue the sale and cease distribution of Suboxone Tablets sublingual (CIII) in the US from March 18, 2013, in light of the analysis evidencing an increased risk of pediatric exposure.

Dr Tim Baxter, global medical director, Reckitt Benckiser Pharmaceuticals, said that, "As a pioneer in opioid dependence treatment, Reckitt Benckiser Pharmaceuticals strongly believes that child-resistant, unit-dose packaging and increased educational interventions are in the best interest of public health and safety, and we encourage other manufacturers to proactively implement these additional safeguards."

RBP introduced Suboxone Film (buprenorphine and naloxone) sublingual (CIII) in 2010 as a next generation product with enhanced features, including child-resistant, unit-dose packaging. This was in response to patient and provider feedback and reports of misuse, abuse, diversion and pediatric exposure associated with the tablets.