Posted by Michael Wonder on 04 Oct 2016
Mundipharma and Orexo announce EU regulatory submission for Zubsolv
4 October 2016 - Mundipharma and Orexo make first EU regulatory submission for Zubsolv (buprenorphine and naloxone) sublingual tablet.
Mundipharma and Orexo AB have announced the submission of a regulatory submission of a marketing authorisation application for Zubsolv (buprenorphine and naloxone) sublingual tablet to the 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.
Mundipharma and Orexo have worked in partnership to complete the submission and the required bio-equivalence study, comparing Zubsolv to Suboxone European buprenorphine and naloxone tablets. The pre-submission meeting with the Rapporteur agreed that the results of the bioequivalence study along with supporting data from previous pharmacokinetic studies performed and Orexo’s extensive clinical program, including data on more than 1,000 opioid dependent patients, were suitable to move forward with the regulatory filing.
Zubsolv has been approved in the US since July 2013 and has resulted in more than 37 million tablets prescribed to date and greater than 44,000 patient year’s exposure, providing additional reassurance of product efficacy and safety.
