11 August 2015 - Orexo AB 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 patient is transitioned from the opioid he or she is dependent on to Zubsolv for long term maintenance treatment of opioid dependence.

“The FDA approval for induction treatment constitutes yet another important milestone for Zubsolv and enables our field force to promote use of Zubsolv from the first day of the patients’ treatment for opioid dependence,” said Nikolaj Sørensen, CEO and President, Orexo AB. “The addition of the new induction indication can further fuel the positive momentum in Zubsolv sales, where we last month saw an increase in market share with 0.2 percentage point from June, reaching 6.1 percent, the highest level since launch. This is the eighth consecutive week with increasing market share on a four week basis since mid-June”.

For more details, go to: http://www.orexo.com/en/Investor-Relations/Press-releases/?guid=1037454