The Uppsala-based company has submitted an application to the U.S. Food and Drug Administration for an expanded label of ZUBSOLV.
Orexo hopes to include initiation of treatment for opioid dependence. The company now anticipates a potential approval of the expanded label during the third quarter 2015.
“The FDA submission constitutes an important milestone for ZUBSOLV. Today we take an important next step in the evolution of the product, applying for a new indication and expanded label. A label including initiation of treatment will enhance product differentiation and enable Orexo to educate physicians in how to optimally use ZUBSOLV from the first day of treatment,” said Nikolaj Sørensen, CEO and President of Orexo AB.
Orexo stated further that the application for initiation of treatment is supported by the data from the ISTART and OX219-007 studies. In the full dataset, Orexo found no difference when comparing ZUBSOLV and generic buprenorphine monotherapy, when used as treatment for the induction of buprenorphine maintenance therapy.