Orexo AB announced on June 17 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 U.S. 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.
Approximately 300 patients will be included in this US trial, and the study is expected to be completed in early 2014.
Source: News-Medical.net – June 17, 2013