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EU regulatory submission for Zubsolv® from Mundipharma and Orexo AB

Mundipharma and Orexo AB have announced the submission of a regulatory submission of a Marketing Authorisation Application (MAA) for Zubsolv (buprenorphine and naloxone) sublingual tablet to the European Medicines Agency (EMA), seeking approval for the treatment of opioid dependence.

If approval is received, 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.

Zubsolv has been approved in the US since July 20131 and has resulted in more than 37 million tablets prescribed to date2 and greater than 44,000 patient year’s exposure, providing additional reassurance of product efficacy and safety.3

Similar to previous studies comparing Zubsolv to Suboxone US Tablet and film formulations4,5,6 the participants in the European study showed strong preference for Zubsolv. When compared with the Suboxone European tablet, Zubsolv was preferred by 77.0 percent (low dose) and 79.4 percent (high dose) of the subjects7 and the tablet dissolve times were faster for Zubsolv than for Suboxone.8

Rachel Gooch, Head of Addiction Therapy, Mundipharma International Limited, said “We are pleased to submit Zubsolv to the EMA for marketing authorization and take a further significant step in our collaboration with Orexo. Opioid dependency is a chronic condition that places a disproportionately large burden on individuals and societies across Europe as well as globally. We are committed to working to support people living with opioid use disorders to have the best possible chance to work towards positive change.”

Nikolaj Sørensen, CEO and President of Orexo AB, said: “With the regulatory filing to EMA of Zubsolv, Orexo has met another major milestone in the efforts to potentially make Zubsolv available for patients world-wide. Opioid dependence is a growing concern globally and with the unique novel product characteristics of Zubsolv such as fast dissolve time, six unique strengths to suit individual patients’ needs and strong patient preference, I am certain Zubsolv could be a welcome alternative for European physicians treating opioid dependence. I am very pleased with the first concrete results of the collaboration with Mundipharma and I am looking forward to working with them to make Zubsolv available in many more countries globally.”


US Food and Drink Administration, July 2013, Medication Guide: Zubsolv®. Available online via: Last accessed 27.09.16

Orexo Data on File

Orexo Data on File

4Gunderson, E. W. et al, October 2015, ‘Effects of a higher-bioavailability buprenorphine/naloxone sublingual table versus buprenorphine/naloxone film for the treatment of opioid dependence during induction and stabilization: A multicentre, randomized trial’, Clinical Therapeutics, 37(10) 2245-2255

Gunderson, E. W. and Sumner, M., March 2016, ‘Efficacy of buprenorphine/naloxone rapidly dissolving sublingual tablets (BNX-RDT) after switching from BNX sublingual film’, American Society of Addiction Medicine, 10(2) 122-128

Fischer, A., Jönsson, M. and Hjelmström, P., 2015, ‘Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in health volunteers’, Drug Development and Industrial Pharmacy, 41(1) 79-84

Mundipharma Data on File ADD-10001

Mundipharma Data on File ADD-10001