European Commission approves Zubsolv to treat opioid dependence.- Orexo AB + Mundipharma.

Orexo AB (publ.) announced that the European Medicines Agency (EMA) has granted a Marketing Authorization (MA) for Zubsolv (buprenorphine and naloxone), a novel rapidly-disintegrating treatment option for opioid dependence. Zubsolv, is a 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 Europe. This offers the potential for finer titration and individualized 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.

Comment: Mundipharma has an agreement with Orexo granting Mundipharma�s network of independent associated companies exclusive global (ex-US) rights to Zubsolv (buprenorphine and naloxone sublingual tablet), a potential new treatment option for patients outside the US with opioid dependence.