Orexo Seeks to Expand Zubsolv Labeling

Orexo AB announced that it has submitted an application to the FDA for an expanded label of Zubsolv (buprenorphine/naloxone) CIII sublingual tablet to include initiation of treatment for opioid dependence.

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.

RELATED: New Treatment for Opioid Dependence Approved

Zubsolv is already indicated for the maintenance treatment of opioid dependence, as part of a complete treatment plan to include counseling and psychosocial support.

For more information call (855) 982-7658 or visit Orexo.com.

Loading links....