Mundipharma and Orexo file for EU approval of Zubsolv in opioid dependence

4 October 2016

UK-based Mundipharma International and Swedish drug developer Orexo (STO: ORX) have announced a European Union regulatory submission for the opioid dependence drug Zubsolv (buprenorphine and naloxone).

If the Marketing Authorization Application (MAA) is approved by the European Medicines Agency (EMA), the buprenorphine and naloxone sublingual tablet would be the first fast-dissolving buprenorphine and naloxone product available in six unique strengths for the treatment of opioid dependence in Europe.

"We are committed to working to support people living with opioid use disorders to have the best possible chance to work towards positive change"

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