Mundipharma and Orexo AB have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Zubsolv® (buprenorphine and naloxone sublingual tablet) for use in the treatment of opioid dependence.
The European Commission will now review the CHMP opinion and a final decision is expected in Q4 2017.
The two companies have worked collaboratively in completing the submission. This was based on data from a bioequivalence study, previous pharmacokinetic studies, and Orexo’s extensive clinical program that includes data on more than 1,000 opioid dependent patients.1
Opioid use disorder is a chronic, relapsing-remitting condition that places a large burden on the individual and society.2 It remains a significant health problemii and it was estimated in 2016 that there were approximately 1.3 million high-risk opioid users in Europe.3 Although estimates vary significantly, the vast majority of high-risk opioid users use heroin.3
Rachel Gooch, Head of Addiction Therapy at Mundipharma International Limited, said: “This positive opinion is an important step for our collaboration with Orexo, and we are committed to working with them to make this important treatment available to patients in Europe. Opioid dependency is a chronic condition, where new options are very much needed, particularly if they can deter misuse. We very much look forward to being able to support the clinical community and their patients in this underserved area of medicine by offering an alternative treatment option.”
Nikolaj Sørensen, President and CEO at Orexo AB, said: “Together with our partner Mundipharma, our ambition is to make Zubsolv available to patients outside the US. The positive CHMP opinion is important progress towards approval to bring Zubsolv to patients suffering from opioid dependence in Europe. I am very pleased with the collaboration with Mundipharma and I look forward to our continuing journey to reach out with this unique product globally. We also share Mundipharma’s commitment to addressing unmet patient needs in opioid dependence, and we remain proud they have chosen to commercialise Zubsolv with us.”
If approved Zubsolv will be the first fast dissolving tablet available in six different strengths, providing a greater choice of therapies to patients and clinicians managing addiction to opioids, including heroin. The Zubsolv formulation has been designed to deter misuse, which it is hoped will give people living with heroin addiction the best possible chance to overcome their challenges.
Under the terms of a 2016 agreement with Mundipharma, Orexo will receive a milestone payment pending achievement of an EU marketing authorisation and commercialisation of Zubsolv. Orexo are also entitled to receive further milestone payments as well as tiered royalties on future net sales.
- Orexo Data on File
- Degenhardt L, et al (2014) The global epidemiology and burden of opioid dependence: results from the global burden of disease 2010 study, Addiction (109), pp1320-1333
- European Monitoring Centre for Drugs and Drug Addiction (2017), European Drug Report 2017. Available online via: http://www.emcdda.europa.eu/system/files/publications/4541/TDAT17001ENN.pdf