The European Medicines Agency has issued a marketing authorisation for Orexo and MundiPharma’s Zubsolv (buprenorphine and naloxone) for opioid dependence.
Zubsolv is a once-daily, sub-lingual formulation of Suboxone (buprenorphine/naloxone), which is marketed by Invidior UK in Europe.
It is the first such therapy to be approved in a choice of six different strengths in region, offering the potential for finer titration and individualised dosing with potentially fewer tablets compared with existing opioid dependence medicine, according to Orexa.
The EU submission was 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.
Opioid dependence is not only a chronic condition but also a significant public health problem, with an estimated 1.3 million high-risk opioid users in Europe.