EMA grants marketing authorisation for Zubsolv for opioid dependence

The European Medicines Agency has issued a marketing authorisation for Orexo and MundiPharma’s Zubsolv (buprenorphine and naloxone) for opioid dependence.

The company's ambition is to make Zubsolv available to patients outside the US, and this approval is an important step in realising this goal

Zubsolv, which is marketed by Invidior UK in Europe, is a once-daily, sublingual tablet licensed for people with opioid dependence within a framework of medical, social and psychological treatment.

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. This offers the potential for finer titration and individualised dosing with potentially fewer tablets compared with existing opioid dependence medicines.

Opioid use disorder is a chronic, relapsing-remitting condition that places a large burden on the individual and society. With an estimated 1.3 million high-risk opioid users in 2016, opioid dependence is a serious health concern in Europe where heroin accounts for a majority of the illicit opioid misuse.

Nikolaj Sørensen, President and CEO at Orexo AB, said: "Our ambition is to make Zubsolv available to patients outside the US, and this approval is an important step in realising this goal. We look forward to continuing our journey with Mundipharma, our partner, reaching out with this unique product globally and introducing an important new option in the care of those suffering from opioid dependence."

The approval does not trigger any milestone payment. Next milestone payment is expected when the commercialisation of Zubsolv is initiated. Orexo is also entitled to receive further milestone payments as well as tiered royalties on future net sales.