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Orexo AB: First Patient Dosed in New Phase III Study Targeted Towards a Future Clinical Indication Expansion for Zubsolv



6/17/2013 9:26:58 AM

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UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Orexo AB (STO:ORX) announces today that the first patient has been dosed with Zubsolv in a phase III study for a new clinical indication for Zubsolv. Currently all buprenorphine/naloxone combination products licensed in the US are indicated for maintenance treatment only. Following review by the United States Food and Drug Administration (FDA), Orexo has initiated a phase III study, which once completed successfully, will be the basis for an application to expand the Zubsolv label with a clinical indication that encompass induction of treatment. Zubsolv is a novel sublingual formulation of buprenorphine and naloxone, with projected approval for use in maintenance treatment of opioid dependence by the FDA by July 2013.

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