EMA approve opioid dependence therapy
European Medicines Agency has issued marketing authorisation for Orexo and MundiPharma’s Zubsolv for opioid dependence.
Zubsolv is a once-daily, sub-lingual formulation of Suboxone (Buprenorphine/Naloxone), which is marketed by Invidior UK in Europe.
It will be the first therapy of its kind 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.