Discontinuation of SUBOXONE® Tablets

February 5, 2013

As of March 18, 2013, Reckitt Benckiser Pharmaceuticals Inc. will discontinue the sale of SUBOXONE® Tablets (buprenorphine and naloxone) Sublingual (CIII) and cease distribution in the United States. SUBOXONE Film (buprenorphine and naloxone) Sublingual (CIII) is still available and will remain on the market.

The decision is based on an analysis of U.S. Poison Control Centers data that found consistently and significantly higher rates of accidental pediatric ingestion of SUBOXONE Tablets than of SUBOXONE Film.

Reckitt Benckiser Pharmaceuticals recognizes that many patients have relied on SUBOXONE Tablets to manage their opioid dependence over the years and encourages patients currently taking SUBOXONE Tablets to talk to their health care professional about immediately transitioning to SUBOXONE Film to minimize any risk to the continuity of their treatment. SUBOXONE® Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions (including anaphylactic shock) have been reported. Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

For more information, please read the Reckitt Benckiser press release.