Orexo AB announce 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.
“Our ambition is to make Zubsolv available to patients outside the US, and this approval is an important step in realizing this goal,” Nikolaj Sørensen, President and CEO at Orexo AB, said. "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."