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Zubsolv (buprenorphine and naloxone) sublingual tablet filed with EU for treatment of opioid dependence- Mundipharma and Orexo

Read time: 1 mins
Last updated:29th Jun 2017
Published:5th Oct 2016
Source: Pharmawand

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. 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, including data on more than 1,000 opioid dependent patients, were suitable to move forward with the regulatory filing. In addition, 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.

Similar to previous studies comparing Zubsolv to Suboxone US Tablet and film formulations 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 subjects and the tablet dissolve times were faster for Zubsolv than for Suboxone.

Comment: Zubsolv is a sublingual formulation of Reckitt Benckiser's Suboxone (buprenorphine/naloxone) which dominates a market that reached sales of about $1.5 billion in 2012 and "continues to display steady growth of more than 15% per year". The Center for Disease Control and Prevention has reported that the deaths of women from overdoses of prescription opioids has increased 415% in the past decade. Opioid dependence affects nearly 5 million people across the US. Although it is a treatable condition, only 20% of Americans receive treatment.

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