Reckitt Benckiser Pharmaceuticals Inc. (RBP) announced that the U.S. Food and Drug Administration (FDA) has denied a Citizen’s Petition filed by the Company. In the Citizen’s Petition, RBP presented a new evaluation of pediatric exposure data and recommended that the FDA adopt more stringent packaging standards and increased educational interventions to help reduce the number of children exposed to buprenorphine-containing products used to treat opioid dependence. The FDA concluded that the safety data presented by RBP did not warrant these additional measures, deciding instead that existing labeling and safety programs were sufficient.
RBP is disappointed with the decision but will continue to work with the FDA on safety enhancements. RBP remains committed to maintaining its own high level standards for safety, including the use of child-resistant, unit-dose packaging for its buprenorphine-based opioid dependence treatment products. It will therefore carry on with the decision to discontinue the sale and cease distribution of SUBOXONE® Tablets (buprenorphine and naloxone) Sublingual (CIII) in the United States as of March 18, 2013, in light of the analysis evidencing an increased risk of pediatric exposure.
“As a pioneer in opioid dependence treatment, Reckitt Benckiser Pharmaceuticals Inc. 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,” says Tim Baxter, M.D., Global Medical Director, Reckitt Benckiser Pharmaceuticals Inc.
The communication from the FDA also informed RBP that two manufacturers (see related article below) have now received approval to produce generic SUBOXONE Tablets. The details of these manufacturers’ proposed safety programs have not been provided.
Source: PRNewswire/Reckitt Benckiser Pharmaceuticals Inc. – February 25, 2013