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.
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.