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Orexo AB Receives FDA Approval for Maintenance Treatment of Opioid Dependence

Thursday, 4 Jul 2013 02:00am EDT 

Orexo AB announced that it has received approval from the United States Food and Drug Administration (FDA) for Zubsolv (buprenorphine/naloxone) sublingual tablet CIII. Zubsolv is indicated for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with an advanced formulation of buprenorphine and naloxone that fully dissolves within minutes. Compared with other buprenorphine/naloxone treatments, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste. Zubsolv will be launched in September 2013 by the Company’s subsidiary in the United States, Orexo US, Inc and partner Publicis Touchpoint Solutions. Orexo’s technology relating to Zubsolv is protected by patents and patent applications in the United States and other markets worldwide. Projected expiry dates for this IP range from 2019 to 2032. 

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