UK-based MundiPharma and Swedish group Orexo’s have filed opioid dependence drug Zubsolv in Europe.
Opioid dependence not only a chronic condition but also a significant public health problem, with an estimated 1.3 million high-risk opioid users in Europe.
Zubsolv is a once-daily, sub-lingual formulation of Suboxone (buprenorphine/naloxone), which is marketed by Invidior UK in Europe.
If approved, Zubsolv would be the first fast-dissolving buprenorphine and naloxone sub-lingual product available in six unique strengths, the firms said.
The submission is based on data from a bioequivalence study comparing Zubsolv to Suboxone as well as data from an extensive clinical programme involving more than 1,000 opioid-dependent patients.
