Zubsolv filed with FDA for expanded label in Opioid Dependence-Orexo
Orexo has announced 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. Orexo anticipates a potential approval of the expanded label during the third quarter 2015.
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.
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