US FDA expands approval of Orexo’s Zubsolv

The US Food and Drug Administration has approved Swedish drug developer Orexo’s (STO: ORX) Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. Orexo shares gained 2.9% to 62.25 Swedish kronor following the announcement.

The approval expands on the current indication for Zubsolv, originally approved by the FDA in July 2013, and is based on data from two Phase III studies demonstrating Zubsolv as 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.

Expected to increase market share