U.S. FDA Approves ZUBSOLV® for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence
Uppsala, Sweden – August 11, 2015 - Orexo AB (publ) announced today that the U.S. Food and Drug Administration (FDA) has approved ZUBSOLV® (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. The approval expands on the current indication for ZUBSOLV, originally approved by the U.S. FDA on July 3, 2013, and is based on data from two Phase III studies demonstrating ZUBSOLV as a an effective treatment for opioid dependence with a solid safety profile. Induction is the initial process a physician performs when a
