Orexo has announced that the US Food and Drug Administration 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 the use of ZUBSOLV from the first day of the patient’s treatment for opioid dependence,” said Nikolaj Sørensen, CEO and President, Orexo. “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 of 0.2 percentage points 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.”
The approval of the expanded indication for ZUBSOLV 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%).