FDA approves extension of indication for Zubsolv (buprenorphine/naloxone CIII sublingual tablet) in opioid dependence- Orexo

The FDA has approved an extension of the indication of Zubsolv (buprenorphine/naloxone CIII sublingual tablet), from Orexo, for induction of buprenorphine maintenance therapy in patients with opioid dependence. The approval expands on the current indication for Zubsolv, originally approved by the 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 approval of the expanded indication was supported by combined data from the Induction, STabilization, Adherence and Retention Trial (ISTART) (Study OX219-006) and Study OX219-007 which showed excellent results with over 90 percent of patients treated with Zubsolv remaining on treatment at Day 3 and using a formulation with a 30 percent lower dose of buprenorphine. No significant differences were observed between the safety profiles of Zubsolv and generic buprenorphine�the most common treatment-related adverse events (?5%) during the induction phase were nausea (Zubsolv � 3.5%; generic buprenorphine � 5.3%) and headache (Zubsolv � 5.2%; generic buprenorphine � 5.5%).