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FDA Approves Buprenorphine/Naloxone (Zubsolv) for Maintenance Treatment of Opioid Dependence

Launch set for September (July 4)

The FDA has approved buprenorphine/naloxone sublingual tablets CIII (Zubsolv) for use as maintenance treatment in patients with opioid dependence. The product should be used as part of a complete treatment plan to include counseling and psychosocial support.

Zubsolv is a once-daily, sublingual tablet consisting of a formulation of buprenorphine and naloxone that dissolves within minutes. According to the manufacturer (Orexo), the product has higher bioavailability, faster dissolve time, and smaller tablet size compared with other buprenorphine/naloxone treatments. The U.S. launch is set for September.

Opioid dependence affects nearly 5 million people in the U.S. Although it is a treatable condition, only 20% of Americans with opioid dependence receive treatment today.

Source: Orexo; July 4, 2013.

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