CHMP recommends approval of Zubsolv (buprenorphine and naloxone sublingual tablet) for use in the treatment of opioid dependence.- Mundipharma and Orexo AB.
Mundipharma and Orexo AB 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.
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.
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