Mundipharma and Orexo announce EU regulatory submission for Zubsolv®
· Mundipharma and Orexo make first EU regulatory submission for Zubsolv® (buprenorphine and naloxone) sublingual tablet. · Zubsolv was approved in the US in 2013 for the maintenance treatment of opioid dependence, as part of a complete treatment plan. · Opioid dependence represents a significant public health problem; across Europe there are an estimated 1.3 million high-risk opioid users. Cambridge, UK and Uppsala, Sweden– 4 October, 2016 Mundipharma and Orexo AB (publ.) have announced the submission of a regulatory submission of a Marketing Authorisation Application (MAA)